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Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit 1 throughout the study period up to 120 days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Patient of child-bearing potential is willing to employ adequate contraception; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
Willing to perform at least two methods of contraception
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least 30 days following last dose of ABT-199\r\n* Women of childbearing potential (WOCBP) includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL)\r\n** Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy\r\n** The following birth control methods are allowed during the study:\r\n*** Barrier methods:\r\n**** Intra-uterine device (IUD)\r\n**** Diaphragm with spermicide\r\n**** Cervical cap with spermicide\r\n**** Condom with spermicide\r\n*** Hormonal method:\r\n**** Hormonal contraceptives (such as the birth control pill)\r\n*** Abstinence (no heterosexual activity)\r\n* Non-vasectomized males must agree to use adequate contraception for at least 30 days after the last dose of ABT-199\r\n** The following birth control methods are allowed during the study:\r\n*** Partner is not WOCBP or is taking hormonal contraceptives\r\n*** Barrier methods:\r\n**** Intra-uterine device (IUD)\r\n**** Diaphragm with spermicide\r\n**** Cervical cap with spermicide\r\n**** Condom with spermicide\r\n*** Abstinence (no heterosexual activity)\r\n** Males must also abstain from sperm donations for at least 90 days after the last dose of ABT-199
If fertile, agree to use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during trial and for up to 90 days after the completion of study treatment
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; women must use an effective method of contraception from 14 days prior to randomization, throughout the treatment period, and for at least 6 months after the last dose of study treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception); hormonal-based methods (e.g., oral contraceptives) are NOT permitted as contraception
Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858, i.e. combination of two forms of effective contraception (defined as hormonal contraception, intrauterine device, transdermal patch, implantable or injectable contraceptive, bilateral tubal ligation etc.).
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.) during the trial and for 6 months after the last administration of BI 836858.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Highly effective methods of contraception:\r\n* Barrier methods\r\n** Male condom with spermicide\r\n** Copper T intrauterine device\r\n** Levonorgestrel-releasing intrauterine system (eg, Mirena) (also considered a hormonal method)\r\n* Hormonal methods\r\n** Implants\r\n** Hormone shot or injection\r\n** Combined pill\r\n** Minipill\r\n** Patch
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; two acceptable methods of birth control thus include the following:\r\n* Condom (barrier method of contraception); AND \r\n* One of the following is required: \r\n** Established use of oral, or injected or implanted hormonal method of contraception by the female partner;\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner;\r\n** Additional barrier method: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner; \r\n** Tubal ligation in the female partner; \r\n** Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months
Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment and for 3 months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: \r\n* Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product \r\n* Oral contraceptive, either combined or progestogen alone \r\n* Injectable progestogen \r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring  \r\n* Percutaneous contraceptive patches \r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months of midostaurin medication; highly effective contraception methods include: \r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception \r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c, or b+c): \r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study; “Women of child-bearing potential” is defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation. Highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Combination of any of the two following\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction; in case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Individuals of non-childbearing potential, or individual of childbearing potential with negative serum pregnancy test =< 7 days prior to randomization and willing to practice total abstinence or use a highly effective method of contraception, as outlined below:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female individual who has had the following:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** NOTE: Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any individual who has had a negative serum pregnancy test, =< 7 days prior to randomization\r\n* Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method (eg, use of a condom AND diaphragm, with spermicide).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods highly effective methods of contraception during dosing and for 150 days after the last dose of PDR001; Note: Highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment\r\n* For female participants, male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that patient\r\n* Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception
Females of child-bearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally post-menopausal for at least 24 consecutive months) must:\r\n* Have a negative serum or urine pregnancy test obtained within 24 hours prior to starting the investigational drug\r\n* Not be breastfeeding\r\n* Agree to use, and be able to comply with, highly effective contraception (failure rate less than 1% per year) without interruption while on study treatment plus 5 half-lives of nivolumab (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post treatment completion; complete abstinence is acceptable if it is in line with the preferred and usual lifestyle of the patient; period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal implants, established and proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods from the options of diaphragm, cervical cap, vaginal sponge, and condom, or progesterone-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action) may be combined to achieve a failure rate of < 1% per year; barrier methods must always be supplemented with the use of a spermicide
Men, even if surgically sterilized (i.e. status post-vasectomy), who are sexually active with WOCBP must agree to follow instructions for effective barrier contraception from the time of signing consent and until 4 months after last dose of protocol-indicated treatment; periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening), the vasectomized male partner should be the sole partner for that patient \r\n* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* Note: In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment; Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction\r\n* Note: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) is she considered not of child bearing potential
For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices
Of child-bearing potential, Subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device from the time of signing the informed consent through at least 4 weeks after the last dose of study drug. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
Double-barrier method (condom plus diaphragm or cervical cup with spermicidal contraceptive sponge, jellies, or cream)
Double-barrier method (condom plus diaphragm or cervical cup with spermicidal, contraceptive sponge, jellies, or cream)
Females must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:\r\n* Women whose sexual orientation precludes intercourse with a male partner\r\n* Women whose partners have been sterilized by vasectomy or other means\r\n* Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable)
Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through 28 days after the last dose of study drug unless patient is practicing true abstinence; acceptable forms of effective contraception include:\r\n* Oral, injected or implanted hormonal methods of contraception\r\n* Tubal ligation\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n* Male sterilization (defined as complete retrograde ejaculation or the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Combination of the two following\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below:\r\n* HIGHLY EFFECTIVE METHODS OF CONTRACEPTION\r\n** Male condoms with spermicide\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by WOCBP subjects or male subject’s WOCBP partner; female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\r\n** Progestogen only hormonal contraception associated with inhibition of ovulation\r\n** Intrauterine hormone-releasing system (IUS)\r\n** Nonhormonal IUDs, such as ParaGard\r\n** Tubal ligation\r\n** Vasectomy\r\n** Complete Abstinence - complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence\r\n* LESS EFFECTIVE METHODS OF CONTRACEPTION\r\n** Diaphragm with spermicide\r\n** Cervical cap with spermicide\r\n** Vaginal sponge\r\n** Male Condom without spermicide\r\n** Progestin only pills by WOCBP subjects or male subject’s WOCBP partner\r\n** Female condom - a male and female condom must not be used together\r\n* UNACCEPTABLE METHODS OF CONTRACEPTION\r\n** Periodic abstinence (calendar, symptothermal, post-ovulation methods)\r\n** Withdrawal (coitus interruptus)\r\n** Spermicide only\r\n** Lactation amenorrhea method (LAM)\r\n* NOTE: azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however, WOCBP participants must still undergo pregnancy testing as described
Subjects of childbearing potential should be willing to use 2 methods of contraception for the course of the study through 120 days after the last dose of study medication; acceptable methods of birth control include: abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections); NOTE: females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year)
Female subjects of childbearing potential (defined as having a menstrual cycle within the past 12 months and not having had a surgical procedure to accomplish sterilization) who are not using highly effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
Double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide
Placement of an intrauterine device
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effected contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Combination of any of the two following (a+b or a+c or b+c)\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception;\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository in case of use of oral contraception, women should have been stable on the same pill before taking study treatment\r\n* Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Subject agrees to use a double barrier method of birth control during the course of study treatment period with enzalutamide and/or cabazitaxel treatment and for at least 3 months after the study is discontinued\r\n* A double-barrier method of contraception involves the use of a condom in combination with 1 of the following: contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam\r\n* Subject who has had a vasectomy at least 6 months prior to starting study treatment period and those whose female sexual partner(s) are more than 55 years of age and postmenopausal for at least 2 years or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) agree to use at least a condom
Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if =< 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug and must agree to use highly effective methods of birth control throughout the study; highly effective methods of contraception include total abstinence, sterilization of patient and/or patient’s partner, or use of combination of two methods, including barrier methods (double barrier method is acceptable), intrauterine device (IUD) or intrauterine system (IUS), and hormonal implants or combined oral contraceptives
If of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment; women of childbearing potential should be advised to use a highly effective method of contraception while receiving everolimus, and for up to 8 weeks after ending treatment; highly effective contraception is defined as either:\r\n* Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female subjects on the study, the vasectomized male partner should be the sole partner for that subject)\r\n* Use of a combination of any two of the following:\r\n** Use of oral, injected, implanted or other hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception women should have been stable on the oral agent before taking study treatment
Male Contraception\r\n* During the course of the clinical trial, sexually active males must use a condom during intercourse while taking the drug and should not father a child in this period and for up to 8 weeks after stopping treatment\r\n* A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Female partners of male patients must also be advised to use one of the following contraception methods: use of (1) oral, injected, implanted or other hormonal methods of contraception, or (2) intrauterine device (IUD) or intrauterine system (IUS), or (3) prior male/female sterilization
Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating vismodegib; for women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required; women of reproductive potential are required to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 24 months after completing therapy; acceptable forms of primary contraception include the following: combination hormonal contraceptives, subcutaneous hormonal implant, hormonal patch, hormonal contraceptives (levonorgestre-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy, and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)
Pregnant or lactating women; patients who are unable or are unwilling to adhere to the required contraceptive methods are excluded from the study\r\n* Women of reproductive potential are required to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 24 months after completing therapy; acceptable forms of primary contraception include the following: combination hormonal contraceptives, subcutaneous hormonal implant, hormonal patch, hormonal contraceptives (levonorgestrel-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)\r\n* Women should not breastfeed a baby while on this study, or for 24 months after completing therapy\r\n* Male patients must use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 2 months after the last dose to avoid exposing a pregnant partner and unborn fetus to vismodegib
Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle; cessation of birth control after this point should be discussed with a responsible physician; investigator will discuss with patient on the above points and the patient agreement will be documented in the source document; the investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol; in case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. The effects of atezolizumab on the developing human fetus are unknown and radiotherapy has known teratogenic effects so women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after completion of atezolizumab administration
The effects of MCS110, trametinib and dabrafenib on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after the last dose of MCS110. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MCS110 administration. Highly Effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject\r\n* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* Double-barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository)
Female subjects who are pre-menopausal or have experienced menopause for less than 2 years and who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting AG-270. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 3 months (females and males) following the last dose of AG-270. Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier methods (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization.
Participants of childbearing potential (as defined above) must be willing to use effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods of contraception are intrauterine devices, bilateral tubal occlusion, vasectomized, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
Examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices.
Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or who commits to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last dose of study treatment.
Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for at least 3 months after\r\ncompletion of treatment; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that patient\r\n* Use of 1 highly effective method of contraception, and 1 additional (barrier) method, at the same time\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Females of childbearing potential and males must be willing to abstain from heterosexual activity* or to use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject’s male partner, contraceptive rod implanted into the skin, or use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive\r\n* Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Appropriate contraception should be used from the time of screening, throughout the duration of study participation, and for four months after the last dose of AZD1775; acceptable methods of contraception include abstinence, tubal ligation, intra-uterine devices, and vasectomized partner; all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by the male sexual partner for intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the participants treating physician should be informed immediately; additionally, male patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing AZD1775; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment
Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug. NOTE: Women are considered to be of childbearing potential unless they are postmenopausal (?45 years of age and has not had menses for greater than 12 consecutive months), surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or not heterosexually active for the duration of the study and at least 120 days after the last dose of study drug.
Established intrauterine device (IUD) or intrauterine system (IUS)
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of atezolizumab\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n* Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
FCBP and male patients whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment
IUD plus one barrier method;
Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method;
2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 30 days after stopping treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate =< 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Key inclusion criteria:\n\n          -  Confirmed CD that is persistent or recurrent as evidenced by all of the following\n             criteria being met (i.e., a, b and c):\n\n               1. mUFC > 1.3 x ULN (Mean of three 24-hour urine samples collected preferably on 3\n                  consecutive days, during screening after washout of prior medical therapy for CD\n                  (if applicable), confirmed by the central laboratory and available before Day 1),\n                  with ?2 of the individual UFC values being > 1.3 x ULN.\n\n               2. Morning plasma ACTH above Lower Limit of Normal\n\n               3. Confirmation (based on medical history) of pituitary source of excess\n\n                  ACTH as defined by any one or more of the following three criteria:\n\n             i. Histopathologic confirmation of an ACTH-staining adenoma in patients who have had\n             prior pituitary surgery. OR ii. MRI confirmation of pituitary adenoma > 6 mm OR iii.\n             Bilateral inferior petrosal sinus sampling (BIPSS) with either CRH or DDAVP\n             stimulation for patients with a tumor ? 6mm. The criteria for a confirmatory BIPSS\n             test are any of the following: Pre-dose central to peripheral ACTH gradient > 2;\n             Post-dose central to peripheral ACTH gradient > 3 after either CRH or DDAVP\n             stimulation\n\n          -  Patients that received glucocorticoid replacement therapy must have discontinued such\n             therapy for at least seven days or 5 half-lives prior to screening, whichever is\n             longer.\n\n          -  Patients with de novo CD can be included only if they are not considered candidates\n             for surgery (e.g., poor surgical candidates due to co-morbidities, inoperable tumors,\n             patients who refuse to have surgical treatment, or surgical treatment is not\n             available).\n\n        Key exclusion criteria:\n\n          -  Patients with pseudo-Cushing's syndrome. This may be diagnosed by a normal late night\n             salivary cortisol value collected during the screening period and after washout of\n             prior CD medication.\n\n          -  Patients with risk factors for QTc prolongation or Torsade de Pointes, including:\n\n        patients with a baseline QTcF > 450 ms for males and QTcF > 460 ms for females; personal or\n        family history of long QT syndrome; concomitant medications known to prolong the QT\n        interval; patients with hypokalemia, hypocalcaemia, or hypomagnesaemia, if not corrected\n        before pre-dose Day 1.\n\n          -  Patients likely to require adrenalectomy, pituitary surgery, or radiation therapy\n             during the placebo-controlled period (Weeks 1-12) for the treatment of severe\n             hypercortisolism or pituitary tumor growth causing compression of the optic chiasm.\n\n          -  Patients with compression of the optic chiasm due to a macroadenoma or patients at\n             high risk of compression of the optic chiasm (tumor within 2 mm of optic chiasm).\n\n          -  Patients who have a known inherited syndrome as the cause for hormone over secretion\n             (i.e. Carney Complex, McCune-Albright syndrome, MEN-1, AIP).\n\n          -  Patients with Cushing's syndrome due to ectopic ACTH secretion or ACTH independent\n             (adrenal) Cushing's syndrome. Pregnant or nursing (lactating) women. 8. Women of\n             child-bearing potential, defined as all women physiologically capable of becoming\n             pregnant, unless they are using highly effective methods of contraception during\n             dosing and for 1 week after completion of dosing. Highly effective contraception\n             methods include: A. Total abstinence (when this is in line with the preferred and\n             usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation,\n             symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of\n             contraception. B. Female sterilization (have had surgical bilateral oophorectomy with\n             or without hysterectomy) or tubal ligation at least six weeks before taking study\n             drug. In case of bilateral oophorectomy, documentation is required (e.g. operative\n             report, pelvic ultrasound or other reliable imaging method). C. Male sterilization (at\n             least 6 months prior to screening). For female subjects on the study the vasectomized\n             male partner should be the sole partner for that subject.\n\n        D. Combination of any two of the following (a+b or a+c, or b+c):\n\n          1. Use of oral*, injected, or implanted hormonal methods of contraception or other forms\n             of hormonal contraception that have comparable efficacy (failure rate <1%), for\n             example hormone vaginal ring or transdermal hormone contraception\n\n          2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n\n          3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault\n             caps) with spermicidal foam/gel/film/cream/vaginal suppository. *In the case of use of\n             oral contraception, women should have been stable on the same pill for a minimum of 3\n             months before taking study drug. Women are considered post-menopausal and not of child\n             bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with\n             an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms)\n             or have had surgical bilateral oophorectomy (with or without hysterectomy), total\n             hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy\n             alone, only when the reproductive status of the woman has been confirmed by follow-up\n             hormone level assessment is she considered not of child bearing potential. Other\n             protocol-defined inclusion/exclusion criteria may apply.
Female subjects of childbearing potential and fertile male subjects must agree to use adequate contraception or abstain from sexual activity from the time of consent through 90 days after the end of study drug. Adequate contraception includes condoms with contraceptive foam; oral, implantable, or injectable contraceptives; contraceptive patch; intrauterine device; diaphragm with spermicidal gel; or a sexual partner who is surgically sterilized or postmenopausal.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 217 days after the last dose of trial treatment; women of childbearing potential (WOCBP) should agree to methods of contraception described in the protocol; WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level > 40 mIU/mL; women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days); and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days; *HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\r\n** Male condoms with spermicide\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject’s WOCBP partner female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\r\n** Non-hormonal IUDs, such as ParaGard \r\n** Tubal ligation\r\n** Vasectomy\r\n** Complete abstinence; complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence\r\n* LESS EFFECTIVE METHODS OF CONTRACEPTION:\r\n** Diaphragm with spermicide\r\n** Cervical cap with spermicide\r\n** Vaginal sponge\r\n** Male condom without spermicide\r\n** Progestin only pills by WOCBP subject or male subject’s WOCBP partner\r\n** Female condom; a male and female condom must not be used together
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for 90 days after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:\r\n* Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 16 weeks after the final dose of study treatment; highly effective contraception is defined as either:\r\n* Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n* Use a combination of the following:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Note: hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed\r\n** Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago\r\n** For women with therapy-induced amenorrhea, oophorectomy or serial measurements of follicle stimulating hormone (FSH) and/or estradiol are needed to ensure postmenopausal status\r\n** NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression
DONOR: Donors must not be pregnant; donors of childbearing potential must use an effective method of contraception, including one or more of the following: intrauterine device, hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods (condom, diaphragm, or cervical cap), or abstinence from the day of signing consent through day +60 of the recipient’s allo- BMT
Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy; women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential\r\n* Acceptable contraception\r\n** Total abstinence from sexual intercourse (minimum one complete menstrual cycle)\r\n** Vasectomized male subjects or vasectomized partner of female subjects\r\n** Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)\r\n** Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 3 months following completion of therapy
Women of childbearing potential (WOCBP) or partners of WOCBP participating in this study must agree to use highly effective contraception while on treatment and for at least 8 weeks after end of treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\r\n* Highly effective contraception methods include combination of:\r\n** Any two of the following:\r\n*** Use of oral, injected or implanted hormonal methods of contraception or\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n** Total abstinence or\r\n** Male/female sterilization\r\n* Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to enrollment; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Female patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the study and for 3 months following the completion of their last treatment; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal
Woman must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of IP.
Female subjects must not be pregnant or at risk to become pregnant during the study. Fertile male and female subjects must agree to use an effective barrier method of birth control to avoid pregnancy (for female subjects a double-barrier method of contraception, for male subjects a condom with spermicide) or total abstinence from the time of providing informed consent until 90 days after the last administration of study drug. Use of oral contraceptives is not allowed.
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, intrauterine device [IUD], ring, condom, sponge, foam)
Patients who are pregnant or breast-feeding are not eligible for this study; fertile patients may not participate unless they have agreed to use contraception during and for 12 months after T cell infusion; highly effective contraception is defined as either:\r\n* Total abstinence: When this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: Patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); [for female study patients, the vasectomized male partner should be the sole partner for that patient]\r\n* Use a combination of the following:\r\n** Hormonal contraception (oral or injected) or placement of an intrauterine device (IUD) or an intrauterine system (IUS)\r\n** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with\r\nspermicidal foam/gel/film/cream/vaginal suppository\r\nNote: Women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential; male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom); a condom is required to be used also by vasectomized men in order to prevent delivery of the study treatment via seminal fluid
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 month days after stopping study drug; highly effective contraception methods include: \r\n* Total abstinence or \r\n* Male or female sterilization or \r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository \r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine device contraceptive [IUDC] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter; female subjects should avoid the use of estrogen-containing contraceptives
Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use one or more of the following forms of contraception from the time of signing the informed consent form through day +100: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence; male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +100
DONOR: female and male donors must agree to use one or more forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +6: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence
Women of child-bearing potential, who are biologically able to conceive and not employing two forms of highly effective contraception; two forms of highly effective contraception must be used throughout the trial and up to 8 weeks after the last dose of study drug (e.g. male condom with spermicide; diaphragm with spermicide; intra-uterine device); oral, implantable, or injectable contraceptives that may be affected by cytochrome P450 interactions are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 14 days prior to starting study drug
PART I: Willingness of female and male subjects to use effective contraception e.g. oral contraceptives, barrier device, intrauterine device, or condoms, during the study and for three months following the last dose of study vaccine; suggested that subjects do not become pregnant or father a child during the study, and for 3 months following receipt of the investigational AdHER2 dendritic cell (DC) vaccine
PART II: Willingness of female subjects to use effective contraception e.g. oral contraceptives, barrier device, intrauterine device, or condoms, during the study and for three months following the last dose of study vaccine; we suggest that subjects do not become pregnant during the study, and for 3 months following receipt of the investigational AdHER2 DC vaccine
Enrollment in the Celgene THALOMID REMS Program:\r\n* If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMS Program\r\n* If enrolled in Arm III of this study, patient must be willing to practice birth control as outlined in the THALOMID REMS Program from the beginning of the study until at least 4 weeks following discontinuation of thalidomide therapy; two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is chosen; contraceptive methods must include at least one highly effective method (e.g. oral contraceptive pills, injections, hormonal patches, intrauterine device [IUD], or implants), AND one additional effective barrier method (e.g. latex condom, diaphragm, cervical cap); if hormonal or IUD contraception is medically contraindicated, another highly effective method or two barrier methods must be used at the same time\r\n* Pregnancy surveillance:\r\n** Patient must have a negative in office pregnancy test sensitive to within 50 mIU/mL (serum or urine) within 24 hours of beginning thalidomide even if continuous abstinence is the preferred method of birth control\r\n** A pregnancy test must be performed weekly during the first 4 weeks of therapy and repeated monthly for patients with regular menses or every 2 weeks for patients with irregular menses\r\n** Negative pregnancy tests are valid for only 7 days\r\n** If irregular bleeding or skipped menses, pregnancy test should be performed and pregnancy counseling given\r\n** If pregnancy occurs during treatment, thalidomide must be immediately discontinued; any suspected lethal exposure must be reported immediately to Celgene Customer Care Center at 1-888-423-5346, and the patient referred to an obstetrician (OB)/gynecologist (GYN) experienced in reproductive toxicity for further evaluation and counseling
Men and women of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device), and women must have a negative serum or urine pregnancy test 1 week before beginning treatment on this trial. Nursing patients are also excluded.
Female: A female is eligible to enter and participate in the study if she is of: a. non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation, hysterectomy alone, hysterectomy and bilateral salpingo-oophorectomy, bilateral salpingo-oophorectomy alone or women who are post-menopausal); or b. childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility; this category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local Institutional Review Board (IRB)/Independent Ethics Committee (IEC):\r\n* Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm)\r\n* Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period\r\n* Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject\r\n* Any intrauterine device (IUD)\r\n* Barrier methods including diaphragm or condom with a spermicide
All men and women of childbearing potential must be willing to use effective contraception as determined by the principal investigator (including but not limited to abstinence, hormonal contraceptives [birth control pills, injections, or implants], intrauterine device [IUD], tubal ligation, vasectomy) from the time of enrollment to at least six months following the last dose of drug
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Acceptable birth control methods:\r\n* Total sexual abstinence i.e., refrain from any form of sexual intercourse in line with the patients’ usual and/or preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least 1 month (for female patients) or 3 months (for male patients) after the last dose of study treatment. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Vasectomized sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia\r\n* Tubal occlusion PLUS male condom\r\n* Intrauterine device PLUS male condom. Provided coils are copper-banded\r\n* Etonogestrel implants (e.g., Implanon, Norplant) PLUS male condom\r\n* Normal and low dose combined oral pills PLUS male condom\r\n* Hormonal shot or injection (e.g., Depo-Provera) PLUS male condom\r\n* Intrauterine system device (e.g., levonorgestrel-releasing intrauterine system -Mirena) PLUS male condom\r\n* Norelgestromin/ethinyl estradiol transdermal system PLUS male condom\r\n* Intravaginal device (e.g., ethinyl estradiol and etonogestrel) PLUS male condom\r\n* Cerazette (desogestrel) PLUS male condom. Cerazette is currently the only highly efficacious progesterone based pill
Women of child-bearing potential, defined as all women capable of becoming pregnant, unless they are using two effective methods of contraception (unless patient is practicing total abstinence) during dosing and for 120 days after last dose, i.e., final vaccine; effective contraception methods include:\r\n* Female sterilization at least eight weeks before taking study treatment\r\n* Male sterilization (at least six months prior to screening)\r\n* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%); in case of use of oral contraception, women should have been stable on the same pill for a minimum of 6 months before taking study treatment
If female and of childbearing potential, is willing to use medically acceptable contraceptive measures for the duration of the study; acceptable methods of contraception include (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as rhythm method or Plan B, sold for emergency use after unprotected sex, are not acceptable methods for routine use
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. a) Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide).
Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom
At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below: \r\n* Highly effective methods of contraception\r\n** Male condoms with spermicide\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by WOCBP subjects or male subject’s WOCBP partner.\r\n** Nonhormonal IUDs, such as ParaGard\r\n** Tubal ligation\r\n** Vasectomy.\r\n**Complete Abstinence*\r\n*** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence. \r\n* Less effective methods of contraception\r\n** Diaphragm with spermicide\r\n** Cervical cap with spermicide\r\n** Vaginal sponge\r\n** Male Condom without spermicide\r\n*** A male and female condom must not be used together\r\n** Progestin only pills by WOCBP subjects or male subject’s WOCBP partner\r\n** Female Condom\r\n*** A male and female condom must not be used together
Women of childbearing potential must have a negative serum or urine pregnancy\r\n* NOTE: Women of childbearing potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* NOTE: Women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\r\n* HIGHLY EFFECTIVE METHODS OF CONTRACEPTION\r\n** Male condoms with spermicide\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject’s WOCBP partner. Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\r\n** Nonhormonal IUDs, such as ParaGard\r\n** Tubal ligation\r\n** Vasectomy\r\n** Complete Abstinence\r\n***Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence\r\n* LESS EFFECTIVE METHODS OF CONTRACEPTION\r\n** Diaphragm with spermicide\r\n** Cervical cap with spermicide\r\n** Vaginal sponge\r\n** Male Condom without spermicide\r\n** Progestin only pills by WOCBP subject or male subject’s WOCBP partner\r\n** Female condom (a male and female condom must not be used together)
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of highly effective methods of contraception from the time of informed consent until 30 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.\r\n* Acceptable non-hormonal birth control methods:\r\n** Total sexual abstinence ie, refrain from any form of sexual intercourse in line with the patients’ usual and/or preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least 1 month (for female patients) or 3 months (for male patients) after the last dose of study treatment. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n** Vasectomized sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia.\r\n** Tubal occlusion PLUS male condom.\r\n** Intrauterine Device PLUS male condom. Provided coils are copper-banded.\r\n* Acceptable hormonal methods:\r\n** Etonogestrel implants (eg, Implanon, Norplant) PLUS male condom.\r\n** Normal and low dose combined oral pills PLUS male condom.\r\n** Hormonal shot or injection (eg, Depo-Provera) PLUS male condom.\r\n** Intrauterine system device (eg, levonorgestrel-releasing intrauterine system - Mirena) PLUS male condom.
Women of childbearing potential (WoCBP) must have a negative serum pregnancy test within 3 days prior to the first dose of study treatment and agree to use highly effective contraception, during the study and for 90 days following the last dose of osimertinib\r\n* Women of childbearing potential (WoCBP): women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation\r\n* Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal\r\n** Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion; tubal occlusion is considered a highly effective method of birth control but does not absolutely exclude possibility of pregnancy; (the term occlusion refers to both occluding and ligating techniques that do not physically remove the oviducts)\r\n* Women who have undergone tubal occlusion should be managed on trials as if they are of WoCBP (e.g. undergo pregnancy testing etc., as required by the study protocol)\r\n* Women will be considered postmenopausal if they are amenorrhoeic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n** Women under 50 years old will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range\r\n** Women over 50 years of age will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments\r\n* Acceptable contraception methods are:\r\n** Total sexual abstinence (abstinence must be for the total duration of the trial and the\r\nfollow-up period)\r\n** Vasectomized sexual partner plus male condom (with participant assurance that partner received post-vasectomy confirmation of azoospermia)\r\n** Tubal occlusion plus male condom\r\n** Intra-uterine device – provided coils are copper-banded, plus male condom\r\n** Intra-uterine system (IUS) levonorgestrel IUS (e.g., Mirena), plus male condom\r\n** Medroxyprogesterone injections (Depo-Provera) plus male condom\r\n** Etonogestrel implants (e.g., Implanon, Norplan) plus male condom\r\n** Normal and low dose combined oral contraceptive pills, plus male condom\r\n** Norelgestromin / ethinylestradiol transdermal system plus male condom\r\n** Intravaginal device (e.g., ethinylestradiol and etonogestrel) plus male condom\r\n** Cerazette (desogestrel) plus male condom (Cerazette is currently the only highly efficacious progesterone based pill)\r\n* Unacceptable Contraception Methods\r\nThe following methods are considered not to be highly effective and are therefore not\r\nacceptable contraceptive methods:\r\n** Triphasic combined oral contraceptives\r\n** All progesterone only pills except, Cerazette\r\n** All barrier methods, if intended to be used alone\r\n** Non-copper containing intra-uterine devices\r\n** Fertility awareness methods\r\n** Coitus interruptus
Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 20 weeks after the last dose of study treatments
Females of childbearing potential: \r\n* Must not be breast feeding;\r\n* Must have a negative serum or urine pregnancy test; \r\n* Must agree to use adequate contraception for a minimum of two weeks prior to receiving study medication until 3 months after discontinuation of the study medication. \r\n** NOTE: Acceptable methods of contraception include total and true sexual abstinence, hormonal contraceptives that are not prone to drug-drug interactions (IUS levonorgestrel intra uterine system [Mirena], medroxyprogesterone injections [Depo-Provera]), copper-banded intra-uterine devices, and vasectomized partner. All hormonal methods of contraception should be used in combination with the use of a condom by their sexual male partner. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)
Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 3 month after the last dose of study medication. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Patients should not father a child for 6 months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication
Female subjects of childbearing potential must be willing to use an adequate method of contraception. Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Acceptable methods of contraception are as follows:\r\n* Single method (one of the following is acceptable): intrauterine device (IUD), vasectomy of a female subject’s male partner, contraceptive rod implanted into the skin.\r\n* Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/ progestin pill or progestin- only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. Abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject.
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include: \r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. \r\n* Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\r\n* Combination of any of the two following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS). \r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository in case of use of oral contraception, women should have been stable on the same pill before taking study treatment.\r\n* Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose; to be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or patients must be surgically sterile
Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:\r\n* Condom with spermicide and one of the following:\r\n** Oral contraceptive or hormonal therapy (e.g. hormone implants)\r\n** Placement of an intra-uterine device\r\n* Acceptable non-hormonal birth control methods include:\r\n** Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period\r\n** Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia\r\n** Tubal occlusion plus male condom with spermicide\r\n** Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded\r\n* Acceptable hormonal methods:\r\n** Etonogestrel implants (eg, Implanon, Norplan) + male condom with spermicide\r\n** Normal and low dose combined oral pills + male condom with spermicide\r\n** Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide\r\n** Intravaginal device + male condom with spermicide (eg, EE and etonogestrel)\r\n** Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 months after termination of study therapy
Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of the therapy. Subjects with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal for at least 24 consecutive months. Females of reproductive potential as well as fertile men and their partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study, and for 4 months (females and males) following the last dose of AG-120 or AG-221. A highly effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier method (e.g., synthetic condoms, diaphragm or cervical cap with spermicidal foam, cream, or gel) or male partner sterilization
Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.
Women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and for 3 months for women and 6 months for men following the date of the last dose of AZD9291 and/or navitoclax:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 3 months after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and 6 months following completion of therapy
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, and all male participants must use effective methods of contraception for at least 12 months following infusion of ET190L1-ARTEMIS T cells and ET190L1-ARTEMIS T cells are no longer present by PCR (with surveillance to cease at 5 years)\r\n* Highly effective contraception may change depending on current Institutional Review Board (IRB) standards but currently include\r\n** Total abstinence, excluded are periodic abstinence utilizing the calendar, ovulation, symptothermal, or post-ovulation methods, or withdrawal technique\r\n** Female sterilization including: 1) surgical bilateral oophorectomy with or without hysterectomy; in the case of oophorectomy alone when the reproductive status has been confirmed by follow up hormone level assessment and, 2) tubal ligation at least six weeks before taking study treatment\r\n** Male sterilization at least 6 months prior to screening; in the case of female participants with a male partner who has had a vasectomy, this partner should be the sole partner for that patient\r\n** Contraception requiring consistent use of BOTH forms listed below must be utilized\r\n*** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%) for example hormonal vaginal ring or transdermal hormonal contraception; women on oral contraception should be stable on the hormone pill for at least 3 months prior to infusion of study drug\r\n*** Barrier method of contraception to include: condom, occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Sexually active males must use a condom during intercourse for 12 months after treatment as they should not father a child in this period; a condom is required to be used by vasectomized men (as well as during intercourse with a male partner)
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g., such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Women of child-bearing potential (WOCBP) and men able to father a child must agree to use highly effective contraception (any contraceptive method with a failure rate of less than 1 percent [%] per year) while on study drug and for 23 weeks (for women) or 31 weeks (for men) after the last dose of study drug\r\n* WOCBP must have a negative serum or urine pregnancy test within 24 hours of initiation of study drug\r\n* WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be defined as post-menopausal\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\r\n* Highly effective contraceptive measures include: stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomy and sexual abstinence\r\n* Contraception is not required for men with documented vasectomy\r\n* Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation \r\n* Women must not be breastfeeding
Patient with reproductive potential who will not agree to use, during the study and for 60 days after the last dose of PF-05082566 or 6 months for T-DM1 or trastuzumab two highly effective method of contraceptive such as implants, injectables, intrauterine devices (IUDs) such as copper T or levonorgestrel-releasing intrauterine system (LNG-IUS), sexual abstinence, vasectomized partner, or condom or occlusive cap (diaphragm or cervical/vault cap) supplemented with the use of a spermicide during treatment
Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after last dose of study drug; two acceptable methods of birth control thus include the following:\r\n* A condom (barrier method of contraception) AND one of the following is required:\r\n** Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner\r\n** Placement of an intrauterine device or intrauterine system by the female partner\r\n** Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner\r\n** Tubal ligation in the female partner performed at least 6 months before screening\r\n** Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), performed at least 6 months before screening
Subjects who are pregnant or breast-feeding are not eligible for this study; fertile subjects may not participate unless they have agreed to use contraception during and for 12 months after T cell infusion\r\n* Highly effective contraception is defined as either:\r\n** Total abstinence: When this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: Patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); [for female study subjects, the vasectomized male partner should be the sole partner for that patient]\r\n** Use a combination of the following:\r\n*** Hormonal contraception (oral or injected) or placement of an intrauterine device (IUD) or an intrauterine system (IUS)\r\n*** Barrier method of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: Woman are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom); a condom is required to be used also by vasectomized men in order to prevent delivery of the study treatment via seminal fluid
Women of child-bearing potential and their male partners also of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\r\n* NOTE: Acceptable forms of birth control are listed below:\r\n** One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom)\r\n** PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
Before enrollment, all women are expected to be not of childbearing potential:\r\n* Not of childbearing potential: postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy\r\n* Of childbearing potential and practicing (during the study and for 3 months after receiving the last dose of study agent) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject)\r\n* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening\r\n* During the study and for 3 months after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction\r\n* Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity (complete abstinence) throughout the study, starting with visit 1 through 5 months after the last dose of study therapy; approved contraceptive methods include, for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for the duration of study participation and for 30 days after the last dose of therapy; highly effective contraceptive measures include: stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone releasing system (IUS); bilateral tubal ligation; vasectomy and sexual abstinence\r\n* WOCBP must have a negative serum or urine pregnancy test within 28 days of initiation of dosing\r\n* Contraception is not required for men with documented vasectomy\r\n* Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential\r\n* Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation
Women of child-bearing potential and men must agree to use highly effective contraception during the study and for 3 months after stopping the study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner: male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c, or b+c):\r\n** A. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** B. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** C. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** D. In case of use of oral contraception women should have been stable on the same pill for a minimum of 30 days before taking study treatment\r\n* Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up\r\nhormone level assessment is she considered not of childbearing potential\r\n* Sexually active males must agree to use a condom during intercourse while taking drug and for 3 months after stopping treatment; men should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Combination of any of the two following (a+b or a+c or b+c): a) use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception; b) placement of an intrauterine device (IUD) or intrauterine system (IUS); c) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository. In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.
Female patients must not be pregnant or breast-feeding; female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s); female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to starting stereotactic radiosurgery (SRS)
Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drugs
Women of childbearing potential (post-menopausal or not of child-bearing potential) is defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:\r\n* Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception)\r\n* Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment; oophorectomy alone\r\nrequires follow up hormone level assessment for fertility\r\n* Male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that subject\r\n* Barrier methods of contraception: condom or occlusive cap\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%); (the dose of the contraceptive should be stable for 3 months)
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 24 weeks (6 months) after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
Women of childbearing potential (WOCBP) must use method(s) of contraception for 30 days + 5 half-lives (60 days) of the study drugs. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. Highly effective birth control in this study is defined as a double barrier method. Examples include a condom (with spermicide) in combination with a diaphragm, cervical cap, or intrauterine device (IUD). The individual methods of contraception should be determined in consultation with the investigator.
Female subjects must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence from heterosexual contact and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method (ie, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; vasectomized partner) and one additional effective barrier method (ie, male condom, diaphragm, cervical cap) 28 days prior to starting pomalidomide, throughout the entire duration of study treatment including dose interruptions and 28 days after discontinuation of pomalidomide.
An intrauterine device (IUD) or intrauterine system (IUS)
Subjects who are pregnant or breast-feeding are not eligible for this study; fertile subjects may not participate unless they have agreed to use contraception during and for 12 months after T cell infusion; highly effective contraception is defined as either:\r\n* Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n* Use a combination of the following (both a+b):\r\n** Hormonal contraception (oral or injected) or placement of an intrauterine device (IUD) or an intrauterine system (IUS)\r\n** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: woman are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom); a condom is required to be used also by vasectomized men in order to prevent delivery of the study treatment via seminal fluid
Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following:\r\n* Practice abstinence from heterosexual activity; OR\r\n* Use (or have their partner use) acceptable contraception during heterosexual activity\r\nAcceptable methods of contraception are:\r\n* Single method (one of the following is acceptable):\r\n** Intrauterine device (IUD)\r\n** Vasectomy of a female subject’s male partner\r\n** Contraceptive rod implanted into the skin\r\n* Combination method (requires use of two of the following):\r\n** Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)\r\n** Cervical cap with spermicide (nulliparous women only)\r\n** Contraceptive sponge (nulliparous women only)\r\n** Male condom or female condom (cannot be used together)\r\n** Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\r\n* Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Electronic Research Collection (ERC)s/Institutional Review Board (IRB)s; periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception\r\n* If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region\r\n* Subjects should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study subjects of childbearing potential must adhere to the contraception requirement (described above) from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of trial therapy; if there is any question that a subject of childbearing potential will not reliably comply with the requirements for contraception, that subject should not be entered into the study
Women of child-bearing potential and men must agree to use adequate contraception as described below; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\r\n* For women of childbearing potential:\r\n** Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year as outlined below\r\n** Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10–14 days and again within 24 hours prior to prescribing Revlimid for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid risk evaluation and management strategy [REMS]) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid; FCBP must also agree to ongoing pregnancy testing\r\n** A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n** Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n** The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* For men:\r\n** Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\r\n** With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year as noted below; men must refrain from donating sperm during this same period\r\n** With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo\r\n** The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception
Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 90 days after the end of study treatment. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months).
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (a) appropriate method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
Female subjects of childbearing potential and their male partners, and male subjects must be willing to use a highly effective method of contraception from the time consent is signed until 6 months after treatment discontinuation; highly effective forms of contraception include complete sexual abstinence or use of a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year; barrier methods (ex: condom) used alone, periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
For all women of childbearing potential, a negative pregnancy test must be obtained at the baseline visit before starting study treatment; for women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year; barrier methods must always be supplemented with the use of a spermicide
If a WOCP, agree to use during the study and for at least one month after the last dose of study drug a medically acceptable method of birth control [such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence.];
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception; adequate contraception is defined as:\r\n* Total abstinence or\r\n* Male or female sterilization or\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.
Negative urine or serum pregnancy test for women of childbearing potential; all women of childbearing potential must agree to use an effective barrier method of contraception (either an intrauterine device [IUD] or double-barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month after discontinuation of the study drugs; male subjects should use effective barrier method of contraception during the treatment period and for at least 3 months after discontinuation of the study drugs
Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during and after the trial
Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration; WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; approved forms of birth control:\r\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\r\n* Progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)\r\n* Intrauterine device, intrauterine hormone-releasing system\r\n* Bilateral tubal occlusion/ligation\r\n* Vasectomized partner\r\n* Barrier contraception\r\n* Sexual abstinence
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Women of childbearing potential and fertile men who are sexually active must agree to use a highly effective method of contraception (less than [<] 1 percent [%] / year failure rate) during the study and for 90 days after the last dose of study drug. Contraception must be consistent with local regulations regarding the use of birth control methods for participants participating in clinical trials. When a woman is of childbearing potential the following are required: Participants must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly). Examples of highly effective contraceptives for women include user-independent methods (for example, implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; vasectomized partner) and user-dependent methods (for example: combined [estrogen- and progestogen-containing] hormonal contraception associated with inhibition of ovulation [oral/intravaginal/ transdermal]; progestogen-only hormone contraception associated with inhibition of ovulation [oral/injectable]. In addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (for example a condom with spermicidal foam/gel/film/cream/suppository). Additionally, a man who is sexually active with a woman who is pregnant must use a condom. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose of study drug
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Requirement to use contraception prior to, during and after the completion of the study; women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of the study and 4 months after completion of anetumab ravtansine or pembrolizumab administration; acceptable methods of contraception are:\r\n* Single method (1 of the following is acceptable):\r\n** Intrauterine device (IUD)\r\n** Vasectomy of a female patient’s male partner\r\n** Contraceptive rod implanted into the skin\r\n* Combination method (requires use of 2 of the following):\r\n** Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)\r\n** Cervical cap with spermicide (nulliparous women only)\r\n** Contraceptive sponge (nulliparous women only)\r\n** Male condom or female condom (cannot be used together)\r\n** Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\r\n* Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the patient’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Institutional Review Boards (IRBs); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception\r\n* If there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
During screening, while taking study drug, and until 30 days after taking the final dose of study drug, women of childbearing potential (WOCBP) must practice one of the following methods of birth control\r\n* Use double-barrier contraception method defined as male use of a condom and female use of a barrier method (e.g., contraceptive sponge, spermicidal jelly or cream, diaphragm [always use with spermicidal jelly/cream])\r\n* Use of hormonal contraceptives (oral, parenteral, vaginal, or transdermal) for at least 3 months before the first study drug administration\r\n* Use of an intrauterine device\r\n* Have a male partner who has had a vasectomy (at least 6 months prior to study enrollment)\r\n* Or must abstain from sexual intercourse completely
During screening, while taking study drug, and until 30 days after taking the final dose of study drug, men who are sexually active with WOCBP must practice one of the following methods of birth control:\r\n* Have had a vasectomy (at least 6 months prior to study enrollment)\r\n* Use double-barrier contraception method defined as male use of a condom and female use of a barrier method (e.g., contraceptive sponge, spermicidal jelly or cream, diaphragm [always use with spermicidal jelly/cream])\r\n* Partner use of an intrauterine device\r\n* Partner use of hormonal contraceptives (oral, parenteral, vaginal, or transdermal) for at least 3 months before the first study drug administration\r\n* Or must abstain from sexual intercourse completely
At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below:\r\n* HIGHLY EFFECTIVE METHODS OF CONTRACEPTION\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) by WOCBP subject or male subject’s WOCBP partner\r\n** Nonhormonal IUDs \r\n** Tubal ligation \r\n** Vasectomy\r\n** Complete abstinence\r\n*** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence\r\n* LESS EFFECTIVE METHODS OF CONTRACEPTION\r\n** Diaphragm with spermicide \r\n** Cervical cap with spermicide \r\n** Vaginal sponge \r\n** Male condom without spermicide \r\n** Male condoms with spermicide \r\n** Progestin only pills by WOCBP subject or male subject’s WOCBP partner \r\n** Female condom\r\n*** A male and female condom must not be used together
For women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to the start of the study; women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of the study; medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use; if you do become pregnant during this study or if you have unprotected sex, you must inform your study physician immediately
For men who are sexually active, must agree to use a two medically acceptable forms of birth control (one of which must include a condom as a barrier method of contraception) in order to be in this study; medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide; contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use; men must also agree to inform their partner of the potential for harm to an unborn child; she should know that if pregnancy occurs, the subject will need to report it to the study doctor, and she should promptly notify her doctor; the study doctor will ask if the subject’s partner is willing to provide updates on the progress of the pregnancy and its outcome; if the subject’s partner agrees, this information will be provided to Pfizer, Inc. for safety monitoring follow-up
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); a highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system-Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch)
Women of child-bearing potential (WCBP), defined as all women capable of becoming pregnant, won't use highly effective methods of contraception during the study and 12 weeks after. Highly effective contraception methods include combination of any two of the following:\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization\r\n* Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study entry. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
Subject of childbearing potential is willing to use effective methods of birth control include: 1) use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2) intrauterine devices (IUDs); 3) using 2 barrier methods (each partner must use 1 barrier method) with a spermicide; males must use the male condom (latex or other synthetic material) with spermicide; females must choose either a diaphragm with spermicide, or cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge); female patients of childbearing potential must have a negative urine pregnancy test no more than 21 days prior to starting study drug; 4) for male participant, they must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of investigational product
Women of child-bearing potential must agree and commit to use of a highly effective double-barrier method of contraception (e.g., a combination of male condom with an intravaginal device such as the cervical cap, diaphragm, or vaginal sponge with spermicide) or a non-hormonal method, from the signing of informed consent until 28 days after the last dose of neratinib and 7 months after the last dose of trastuzumab, or consent to total sexual abstinence (abstinence must occur from randomization and continue for 28 days after the last dose of neratinib and 7 months after the last dose of trastuzumab); men without confirmed vasectomy must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of investigational products, or consent to total sexual abstinence (abstinence must occur from randomization and continue for 3 months after the last dose of study medication)
If fertile, willing to use highly effective form of contraception (defined as a combination of at least two of the following methods: condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during the dosing period and for at least 4 months after the dosing period
Women of child­bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after the last dose of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post­-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Women of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (3 months after the last dose of daratumumab for women)
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 90 days after the last dose of study medication; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence
Male or female patients of reproductive potential who are not employing an effective method of birth control; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide cervical/vault cap or intrauterine device), and abstinence
Female subjects are eligible to enter the study if they are either:\r\n* Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n** Has had a hysterectomy, or\r\n** Has had a bilateral oophorectomy, or\r\n** Has had a bilateral tubal ligation, or\r\n** Is post-menopausal (demonstrates total cessation of menses for greater than or equal to 1 year) OR\r\n* Of childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following contraceptives:\r\n** An intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n** Vasectomized partner who is sterile prior to the subject’s entry and is the sole sexual partner for that woman\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, during the clinical trial, and for at least 14 days after the last dose of investigational product\r\n** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm
Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception
Male and female subjects must agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Pregnant or breast-feeding; female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used with spermicide; there should be no risk of transmission of a mother to her fetus after receiving intracranial PVSRIPO; as such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contraindicated during pregnancy; partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected
Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening including 30 days after discontinuation of the study drug) to avoid becoming pregnant or fathering a child; A) females of non-childbearing potential are defined as women who (a) are equal to or greater than 55 years of age with history of amenorrhea for 1 year, OR (b) are surgically sterile for at least 3 months; B) for females of childbearing potential, or for males, appropriate precautions are those that are at least 99% effective in preventing the occurrence of pregnancy; these methods should be communicated to the subjects and their understanding confirmed: a) double barrier methods; b) condom with spermicide in conjunction with use of an intrauterine device (IUD); c) condom with spermicide in conjunction with use of a diaphragm; d) oral, injectable, or implanted contraceptives; e) tubal ligation or vasectomy (surgical sterilization)
All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device [IUD]) with their partner from entry into the study through three months after the last dose
Childbearing potential includes any female who has had a negative serum pregnancy test within 7 days of study registration, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n* Complete abstinence from sexual intercourse for 14 days before starting treatment, through the treatment, and for at least 1 month after the last dose of temozolomide\r\n* Oral contraceptive, either combined or progestogen alone. A second barrier method is required during the first month of treatment with oral contraceptives\r\n* Injectable progesterone\r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring\r\n* Percutaneous contraceptive patches\r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). Female participants who are lactating should discontinue nursing prior to the first dose of temozolomide and should refrain from nursing throughout the treatment period and for 42 days following the last dose of lomustine.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication; adequate contraception is defined as 2 methods of birth control (e.g., hormonal contraceptives, intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide) or prior surgical sterilization, or abstinence from heterosexual activity
Premenopausal patients must agree to use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib; adequate contraception is defined as one highly effective form (i.e. abstinence, male or female sterilization) OR two effective forms (e.g. non-hormonal intrauterine device [IUD] and condom/occlusive cap with spermicidal foam/gel/film/cream/suppository); hormonal contraceptive methods are not allowed; patients with hormonal IUD in place are eligible provided the hormonal IUD is removed or replaced by a non-hormonal IUD prior to treatment initiation
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Inclusion Criteria:\n\n        Male or female patients with a diagnosis of CML-CP ? 18 years of age\n\n        Patients must meet all of the following laboratory values at the screening visit:\n\n          -  < 15% blasts in peripheral blood and bone marrow\n\n          -  < 30% blasts plus promyelocytes in peripheral blood and bone marrow\n\n          -  < 20% basophils in the peripheral blood\n\n          -  ? 50 x 109/L (? 50,000/mm3) platelets\n\n          -  Transient prior therapy related thrombocytopenia (< 50,000/mm3 for ? 30 days prior to\n             screening) is acceptable\n\n          -  No evidence of extramedullary leukemic involvement, with the exception of\n             hepatosplenomegaly\n\n        BCR-ABL ratio ? 1% IS according to central laboratory at the screening examination\n\n        Prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib,\n        dasatinib, radotinib or ponatinib)\n\n        Failure or intolerance to the last previous TKI therapy at the time of screening (adapted\n        from the 2013 ELN Guidelines Bacarrani 2013)\n\n          -  Failure is defined for CML-CP patients (CP at the time of initiation of last therapy)\n             as follows. Patients must meet at least 1 of the following criteria.\n\n          -  Three months after the initiation of therapy: No CHR or > 95% Ph+ metaphases\n\n          -  Six months after the initiation of therapy: BCR-ABL ratio > 10% IS and/or > 65% Ph+\n             metaphases\n\n          -  Twelve months after initiation of therapy: BCR-ABL ratio > 10% IS and/or > 35% Ph+\n             metaphases\n\n          -  At any time after the initiation of therapy, loss of CHR, CCyR or PCyR\n\n          -  At any time after the initiation of therapy, the development of new BCR-ABL mutations\n\n          -  At any time after the initiation of therapy, confirmed loss of MMR in 2 consecutive\n             tests, of which one must have a BCR-ABL ratio ? 1% IS\n\n          -  At any time after the initiation of therapy, new clonal chromosome abnormalities in\n             Ph+ cells: CCA/Ph+\n\n          -  Intolerance is defined as:\n\n          -  Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or\n             with persistent grade 2 toxicity, unresponsive to optimal management, including dose\n             adjustments (unless dose reduction is not considered in the best interest of the\n             patient if response is already suboptimal)\n\n          -  Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil\n             count [ANC] or platelets) while on therapy that is recurrent after dose reduction to\n             the lowest doses recommended by manufacturer\n\n        Exclusion Criteria:\n\n        Known presence of the T315I or V299L mutation at any time prior to study entry Known second\n        chronic phase of CML after previous progression to AP/BC Previous treatment with a\n        hematopoietic stem-cell transplantation Patient planning to undergo allogeneic\n        hematopoietic stem cell transplantation\n\n        Cardiac or cardiac repolarization abnormality, including any of the following:\n\n          -  History within 6 months prior to starting study treatment of myocardial infarction\n             (MI), angina pectoris, coronary artery bypass graft (CABG)\n\n          -  Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete\n             left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type\n             II and third degree AV block)\n\n          -  QTcF at screening ?450 ms (male patients), ?460 ms (female patients)\n\n          -  Long QT syndrome, family history of idiopathic sudden death or congenital long QT\n             syndrome, or any of the following:\n\n          -  Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or\n             hypomagnesemia, history of cardiac failure, or history of clinically\n             significant/symptomatic bradycardia\n\n          -  Concomitant medication(s) with a known risk to prolong the QT interval and/or known to\n             cause Torsades de Pointes that cannot be discontinued or replaced 7 days prior to\n             starting study drug by safe alternative medication.\n\n          -  Inability to determine the QTcF interval\n\n          -  Severe and/or uncontrolled concurrent medical disease that in the opinion of the\n             investigator could cause unacceptable safety risks or compromise compliance with the\n             protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary\n             hypertension)\n\n          -  History of acute pancreatitis within 1 year of study entry or past medical history of\n             chronic pancreatitis\n\n          -  History of acute or chronic liver disease\n\n          -  Treatment with medications that meet one of the following criteria and that cannot be\n             discontinued at least one week prior to the start of treatment with study treatment\n\n          -  Moderate or strong inducers of CYP3A\n\n          -  Moderate or strong inhibitors of CYP3A and/or P-gp\n\n          -  Substrates of CYP3A4/5, CYP2C8, or CYP2C9 with narrow therapeutic index\n\n          -  Women of child-bearing potential, defined as all women physiologically capable of\n             becoming pregnant, unless they are using highly effective methods of contraception\n             during dosing and for 3 days after last dose of ABL001. Highly effective contraception\n             methods include:\n\n          -  Total abstinence (when this is in line with the preferred and usual lifestyle of the\n             subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation\n             methods) and withdrawal are not acceptable methods of contraception\n\n          -  Female sterilization (have had surgical bilateral oophorectomy (with or without\n             hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking\n             study treatment). In case of oophorectomy alone, only when the reproductive status of\n             the woman has been confirmed by follow up hormone level assessment\n\n          -  Male sterilization (at least 6 months prior to screening). The vasectomized male\n             partner should be the sole partner for that subject.\n\n          -  Use of oral, injected or implanted hormonal methods of contraception or placement of\n             an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal\n             contraception that have comparable efficacy (failure rate <1%), for example hormone\n             vaginal ring or transdermal hormone contraception.\n\n          -  In case of use of oral contraception women should have been stable on the same pill\n             for a minimum of 3 months before taking study treatment.\n\n          -  Women are considered post-menopausal and not of child bearing potential if they have\n             had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile\n             (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral\n             oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at\n             least six weeks ago. In the case of oophorectomy alone, only when the reproductive\n             status of the woman has been confirmed by follow up hormone level assessment is she\n             considered not of child bearing potential.\n\n          -  Sexually active males unless they use a condom during intercourse while taking the\n             drug during treatment and for 3 days after stopping treatment and should not father a\n             child in this period. A condom is required to be used also by vasectomized men as well\n             as during intercourse with a male partner in order to prevent delivery of the drug via\n             semen.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must agree to use highly effective contraception during study treatment and for 120 days after study discontinuation; highly effective contraception is defined as either:\r\n* True Abstinence: When this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner must be the sole partner for that participant\r\n* Use of a combination of any two of the following:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Appropriate hormonal contraceptives (including any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent – including oral, subcutaneous, intrauterine, or intramuscular agents)
Established intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Inclusion Criteria\n\n        Each subject eligible to participate in this study must meet or have all the following\n        criteria:\n\n          1. Is 18 years of age or older.\n\n          2. Can provide written informed consent or have their legal representatives provide\n             written informed consent\n\n          3. Have documented histological or cytological evidence of invasive cancer of the breast,\n             defined by one of the following:\n\n               -  ER+ breast cancer, defined as positive if ? 1% by IHC and HER2 normal, defined as\n                  IHC 0-1+ or IHC 2+(and FISH<2), or FISH < 2.0\n\n               -  TNBC, defined as ER-/PgR- if 0 % by IHC and HER2 normal, defined as IHC 0-1+ or\n                  IHC 2+(and FISH<2), or FISH < 2.0\n\n          4. ECOG PS of 0 or 1 for Females, 0, 1, or 2 for Males.\n\n          5. Undergoing or willing to undergo gonadal suppression:\n\n               -  Female subjects with ER+/HER2 normal tumors must be post-menopausal defined by\n                  local practice. Ovarian suppression with a LHRH analogue to achieve cessation of\n                  regular menses is allowed on study\n\n               -  Male subjects must be undergoing or willing to undergo gonadal suppression whilst\n                  on study drug and continue with the LHRH analogue for the duration of the study\n\n          6. Subjects must have adequate hematopoietic function as evidenced by:\n\n               -  WBC ? 3,000/?l\n\n               -  ANC ? 1,500/?l\n\n               -  Platelet count ? 100,000/?l\n\n               -  HGB ? 9 g/dl and not transfusion dependent\n\n          7. Adequate liver function, including all the following:\n\n               -  Total serum bilirubin ?2.0 x ULN unless the subject has documented Gilbert\n                  syndrome;\n\n               -  Aspartate and alanine aminotransferase (AST & ALT) ?3.0 x ULN or ?5.0 x ULN if\n                  subject has liver metastasis;\n\n               -  Alkaline phosphatase ?3.0 x ULN or ?5 x ULN in case of bone metastasis and/or\n                  hepatic metastasis\n\n          8. Subjects must have adequate renal function as evidenced by a serum creatinine of ? 2.0\n             mg/dl.\n\n          9. Potassium (K+) ?3.5 mEq/L\n\n         10. Women of child-bearing potential must have a negative serum or urine pregnancy test\n             within 72 hours of C1D1.\n\n         11. Women of child-bearing potential and male subjects with a female partner of\n             childbearing potential must use 2 acceptable methods of birth control (one of which\n             must include a condom as a barrier method of contraception) starting at Screening and\n             continuing throughout the study period and for 3 months after final study drug\n             administration i. Two acceptable forms of birth control include:\n\n        1. Condom (barrier method of contraception), and 2. One of the following:\n\n          1. Oral, injected or implanted hormonal contraception\n\n          2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)\n\n          3. Additional barrier methods of contraception: Occlusive cap (diaphragm or\n             cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n          4. Vasectomy or surgical castration ? 6 months prior to Screening. 12. Able to swallow\n             study medication 13. Able to comply with study requirements\n\n        Exclusion Criteria\n\n          1. Received any investigational agent within 5 half-lives of the agent in question; if\n             the half-life is not known, ? 28 days of C1D1.\n\n          2. Received palliative radiotherapy ? 2 weeks of C1D1\n\n          3. Received any other therapeutic treatment for breast cancer ? 2 weeks of C1D1, except\n             for hormonal therapies.\n\n          4. Symptomatic CNS metastases.\n\n          5. History of another invasive malignancy ? 3 years of C1D1.\n\n          6. A QTcF interval >470 msec on the Screening ECG. If the ECG QTcF interval is >470 msec,\n             then the mean QTcF of a triplicate ECGs can be used and if the mean is <470 msec, the\n             subject may be enrolled.\n\n          7. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular\n             fibrillation, atrial fibrillation with rapid ventricular response, torsades de\n             pointes, second degree or third degree atrioventricular heart block without a\n             permanent pacemaker in place).\n\n          8. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart\n             Association (NYHA) functional classification system within the previous 6 months\n\n          9. Initiated a bone modifying agent (e.g. denosumab) ? 28 days of C1D1.\n\n         10. Any medical condition that could preclude their participation in the study, pose an\n             undue medical hazard, or which could interfere with the interpretation of the study\n             results.\n\n         11. A history of seizure ? 2 years of C1D1 or those who require prophylactic anti-seizure\n             medications.\n\n         12. A history of loss of consciousness or transient ischemic attack ? 12 months before\n             C1D1.\n\n         13. Known active HIV, Hepatitis B, or Hepatitis C infections.\n\n         14. Known or suspected hypersensitivity to seviteronel, or any components of the\n             formulation.\n\n         15. Any other condition which in the opinion of the investigator would preclude\n             participation in the study.
Women of childbearing potential in agreement to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood; this may be a period of several years; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Female subject is either post-menopausal, surgically sterilized, or willing to use and acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab
CELL PROCUREMENT: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol\r\n* Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the last dose of study therapy
LYMPHODEPLETION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
iC9-CAR19 CELL INFUSION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 6 months after the last dose of brentuximab vedotin
Male and female subjects who agree to use both a highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g. condoms, vaginal ring, sponge, etc) during the period of therapy and for 90 days after the last dose of study drug
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for four months following the last dose
Females who are pregnant or breast-feeding; female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used with spermicide; as such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contra-indicated during pregnancy; partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity (complete abstinence) throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; non-pregnant, non-breast-feeding women may be enrolled if they are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) amenorrheic for < 2 years without a hysterectomy and oophorectomy and with a documented follicle stimulating hormone (FSH) value in the postmenopausal range, or 4) not heterosexually active for the duration of the study, or 5) heterosexually active and willing to use 2 methods of birth control (which is also required for the female partners of male patients)\r\n* Male patients must agree to use an adequate method of contraception, or to abstain from heterosexual activity (complete abstinence), starting with the first dose of study drug through 120 days after the last dose of study therapy
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib; highly effective contraception is defined as either:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to enrolling); for female patients on the study the vasectomized male partner should be the sole partner for that patient\r\n* Use of a combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug
Females of childbearing potential and male subjects with female partners of childbearing potential must agree to avoid pregnancy by using an adequate method of contraception (2 barrier method or 1 barrier method with a spermicide or intrauterine device for 2 weeks prior to screening, during and 12 weeks after the last dose of trial medication; adequate methods of contraception are provided as examples; other acceptable and effective methods of birth control are also permitted (e.g., abstinence)
Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued
Agreement to exercise appropriate use of contraception; subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: \r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception \r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment \r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Combination of any of the two following (a+b or a+c or b+c) \r\n** a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception \r\n** b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n** c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository In case of use of oral contraception, women should have been stable on the same pill before taking study treatment \r\n* Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction
For women of childbearing potential using a contraceptive pill, an additional barrier method is necessary. A list of adequate contraception methods is provided in the patient information.
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of deferasirox\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment; effective contraception methods include:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Total abstinence or (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception \r\n** Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment \r\n** Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partner should be the sole partner for that subject \r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential; sexually active males must use a condom during intercourse while taking drug and for 28 days after stopping study medication and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Male and female subjects must agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods]), and latex or non-latex condom with or without a spermicidal agent, diaphragm with spermicide; cervical cap with a spermicide; sponge with a spermicide
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: a) agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR b) latex or non-latex condom with or without a spermicidal agent, diaphragm with spermicide; cervical cap with a spermicide; sponge with a spermicide
Be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (male and female subjects of childbearing potential; acceptable methods of contraception are as follows: A) single method (one of the following is acceptable): a) intrauterine device (IUD); b) vasectomy of a female subject’s male partner; c) contraceptive rod implanted into the skin B) combination method (requires use of two of the following): a) diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide); c) cervical cap with spermicide (nulliparous women only); d) contraceptive sponge (nulliparous women only); e) male condom or female condom (cannot be used together); f) hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection; abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethical Review Committees (ERCs)/Institutional Review Boards (IRBs); periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception; if a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region
Men must agree to use adequate contraception (abstinence, vasectomy) or female partner must use (intrauterine device [IUD], hormonal [birth control, pills, injections, or implants], tubal ligation) prior to study entry and for up to 5 months after the last dose
Be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (male and female subjects of childbearing potential; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; acceptable methods of contraception are as follows: single method (one of the following is acceptable): intrauterine device (IUD), vasectomy of a female subject’s male partner, contraceptive rod implanted into the skin; combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection; abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectable, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Patients with reproductive potential must be willing to use, in combination with her partner, 2 acceptable methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after study duration; subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g., history of vasectomy) are not required to use additional contraceptive measures
Male and female subjects who agree to use both a highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 30 days after the last dose of study drug
Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any of the two following (a+b or a+c or b+c): a. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception; b. placement of an intrauterine device (IUD) or intrauterine system (IUS); c. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill before taking study treatment\r\n* Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
At a minimum, subjects must agree to use one highly effective (which have a failure rate of < 1% when used consistently and correctly) OR one less effective method of contraception as listed below:\r\n* WOCBP and female partners of male subjects, who are WOCBP, are expected to use one of the highly effective methods of contraception listed below; male subjects must inform their female partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner; contraception methods are as follows:\r\n** Progestogen only hormonal contraception associated with inhibition of ovulation\r\n** Hormonal methods of contraception including oral contraceptive pills containing combined estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena\r\n** Nonhormonal IUDs, such as ParaGard\r\n** Bilateral tubal occlusion\r\n** Vasectomised partner with documented azoospermia 90 days after procedure\r\n** Intrauterine hormone-releasing system (IUS)\r\n** Complete abstinence\r\n* Less effective methods of contraception\r\n** Diaphragm with spermicide\r\n** Cervical cap with spermicide\r\n** Vaginal sponge with spermicide\r\n** Male or female condom with or without spermicide\r\n** Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action\r\n* Unacceptable methods of contraception\r\n** Periodic abstinence (calendar, symptothermal, post-ovulation methods)\r\n** Withdrawal (coitus interruptus)\r\n** Spermicide only\r\n** Lactation amenorrhea method (LAM)
Patients of childbearing potential (women who are postmenopausal for < 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject’s entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide
Negative urine or serum pregnancy test for females of childbearing potential; all females of childbearing potential must use an effective barrier method of contraception (either an intrauterine device [IUD] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter
Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 highly effective barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit 1 and at least 5 months from the last dose of nivolumab; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception\r\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Although extremely rare in this population that fertility would still be an option, a female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment; sexually active pre-menopausal female subjects of child-bearing potential must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug; effective birth control includes: intrauterine device (IUD) plus one barrier method; oral, implantable or injectable contraceptives plus one barrier method; 2 barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
Females of child-bearing potential should use reliable methods of contraception from the time of screening until 3 months after discontinuing osimertinib; acceptable methods of contraception include total and true sexual abstinence, tubal ligation, hormonal contraceptives that are not prone to drug-drug interactions (intra uterine system [IUS] levonorgestrel intra uterine system (Mirena), medroxyprogesterone injections (Depo-Provera), copper-banded intra-uterine devices, and vasectomized partner; all hormonal methods of contraception should be used in combination with the use of a condom by their male sexual partner for intercourse
Female subject is either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Patients of childbearing potential (i.e., women of childbearing potential and men with female partners of childbearing potential) who are unwilling to follow strict contraception requirements (including 2 reliable methods in combination: 1 non-hormonal, highly-reliable method [diaphragm, condoms with spermicidal foam or jelly, or sterilization] plus 1 additional reliable method [birth control pills, intrauterine device, contraceptive injections, or contraceptive patches]) before entry and throughout the study, up to and including the 30-day non-treatment follow-up period
Females of child bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum or urine beta human chorionic gonadotropin (b-hCG) pregnancy test results within 7 days prior to the first dose of study treatment, and must agree to use highly effective methods of contraception during dosing and for 3 months after the last dose of study treatment; highly effective methods of contraception include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least six months prior to screening) with the appropriate post-vasectomy documentation of absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be sole partner for that subject\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or who have had a bilateral tubal ligation or hysterectomy
Female subjects who are pregnant/breast-feeding or who are of reproductive potential and not employing acceptable methods of birth control; acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the patient, tubal ligation, vasectomized partner, barrier methods (e.g., cap plus spermicide, sponge plus spermicide, diaphragm plus spermicide, or male condom plus a spermicide), intrauterine device methods (e.g., Copper T or Levonorgestrel-releasing intrauterine system), or hormonal methods (e.g., any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent) and that is administered via the oral, subcutaneous, transdermal, intrauterine, or intramuscular route as an implant, hormone shot or injection, combined pill, minipill or patch; all methods of contraception should be used in combination with the use of a condom by their male sexual partner for intercourse
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment must be used by both sexes (= female patients and their male partners); highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of the following (a+b or a+c, or b+c):\r\n** a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\nNote: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception because BGJ398 has not been characterized with respect to the potential to interfere with pharmacokinetics (PK) and/or the effectiveness of OCs\r\nPost-menopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study and for 4 months after the last dose of APX005M or pembrolizumab such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control
Females of childbearing potential must also refrain from egg cell donation for 180 days after the final dose of investigational product; \r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgesterl-releasing intrauterine system - Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch); non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days 1-180 post last dose; in addition, they must refrain from sperm donation for 180 days after the final dose of investigational product
Pregnancy or lactation at the time of registration; for women of childbearing potential, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:\r\n* Sexually active males should use a condom during intercourse while taking drug and for 8 weeks after the final dose of study treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment; highly effective contraception methods include:\r\n** Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods]) and withdrawal are not acceptable methods of contraception\r\n** Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n** Combination of the following (a+b):\r\n*** a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** b. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Fertile patients must use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during and for six months after completion of treatment
Intrauterine device (IUD)
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, must agree to use highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment; highly effective contraception methods include: \r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects the \tvasectomized male partner should be the sole partner\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%); for example, hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception
Women of childbearing potential and men must agree to use effective methods of birth control for the duration of the study and 6 months after; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy
Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of MEDI4736 and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of MEDI4736 and tremelimumab\r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not post-menopausal (defined as 12 months with no menses with postmenopausal gonadotropin levels, luteinizing hormone [LH] and follicle-stimulating [FSH], or postmenopausal estradiol levels within the postmenopausal range according to local guidelines without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, Copper T intrauterine device, levonorgestrel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 15 days after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence\r\n* Female sterilization-bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks before starting study treatment; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male sterilization of subject partner- vasectomy at least 6 months prior to screening\r\n* Combination of any two of the following:\r\n** Use of oral, injected, or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal .foam/gel/film/cream/vaginal suppository\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 3 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* * Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception \r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following: placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository, total abstinence or male/female sterilization; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
CAPMATINIB EXCLUSION CRITERIA: Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after the last dose of capmatinib; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
CERITINIB EXCLUSION CRITERIA: Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after the last dose of capmatinib; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment
CERITINIB EXCLUSION CRITERIA: Male sterilization (at least 6 months prior to screening); the vasectomized male partner should be the sole partner for that subject; use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception
REGORAFENIB EXCLUSION CRITERIA: Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after the last dose of entrectinib; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit and continue throughout study mandated treatment and for 90 days after the final dose of study drug; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Male or female patients of child-producing potential must agree to use two methods of the following contraceptive: condoms,intrauterine device (IUD), contraceptives (oral or parenteral), Implanon, injectables during the study and up to 90 days post the last day of study treatment.
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient; combination of any of the two following (a+b or a+c or b+c); use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill before taking study treatment; Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year; barrier methods must always be supplemented with the use of a spermicide
The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and agree to continue for 3 months after the last dose of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Female patients who are of child-bearing potential (as defined above) should use enhanced methods of contraception from the time of screening until 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician; acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the subject, tubal ligation, vasectomized partner, and methods listed in the table below; all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Effective methods of contraception:\r\n* Barrier methods\r\n** Cap plus spermicide\r\n** Sponge plus spermicide\r\n** Diaphragm plus spermicide\r\n* Intrauterine device methods\r\n** Copper T\r\n** Levonorgestrel-releasing intrauterine system (e.g., Mirena); this is also considered a hormonal method\r\n* Hormonal methods\r\n** Any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents) such as\r\n*** Implants\r\n*** Hormone shot or injection\r\n*** Combined pill\r\n*** Minipill\r\n*** Patch
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), or if the patient is post-menopausal, the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation; (Note: pregnant patients are excluded)
Women of child-bearing potential must consent to use adequate contraception during the course of the study: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use
Women of child-bearing potential must consent to use adequate contraception during the course of the study; female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use
Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy; women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle)\r\n* Vasectomized male subjects or vasectomized partner of female subjects \r\n* Intrauterine device \r\n* Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 3 months following completion of therapy
Women of childbearing potential and all men must agree to use an approved form of contraception (e.g. oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm, condom, abstinence or surgical sterility) prior to study entry and for the duration of study participation through 30 days after the last dose of the last treatment drug. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Acceptable forms of birth control include condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility (tubal ligation or a partner that has undergone a vasectomy), or oral contraceptives, OR the subject must agree to completely abstain from heterosexual intercourse.; abstinence at certain times of the cycle only, such as during the days of ovulation, after ovulation and withdrawal are not acceptable methods of birth control
Two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 4 weeks after discontinuing study drugs, and
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; appropriate methods of birth control include the following: any 2 of the following methods used together: birth control implants, injections, or pills (except for progesterone only pills), intrauterine device (IUD), vasectomy, tubal ligation, barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); male condom with spermicide and diaphragm; male condom with spermicide and cervical cap; unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time
Subjects of childbearing potential should be willing to use effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; effective methods of birth control include: \r\n* Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin)\r\n* Intrauterine devices (IUDs)\r\n* Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide; males must use the male condom (latex or other synthetic material) with spermicide; females must choose either a diaphragm with spermicide, or cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge)
Premenopausal and using an acceptable form of birth control. Acceptable forms of birth control include: hormonal contraceptives (implantable, oral, patch) used for ? 2 months prior to screening or double barrier methods (any combination of two of the following: intrauterine device [IUD], male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). All premenopausal females must have a negative urine or serum pregnancy test at screening and on Day 1 prior to first PRTX-100 treatment.
Combination of any of the two following\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill before taking study treatment; note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical/vault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial; nursing patients are excluded; sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug; pregnant and nursing patients are excluded
Women of childbearing potential must practice contraception; females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, Depo Provera, or injectable contraceptives, intrauterine devices, and tubal ligation; male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, prior to study entry and for at least 3 months after the last dose of study drug
Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine beta-hCG [human chorionic gonadotropin]) within 3 days of registration; sexually active pre-menopausal women of childbearing potential must agree to use adequate, highly effective contraceptive measures, starting with the first dose of study drug and for 120 days after the last dose of last study drug; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable, or injectable contraceptives plus one barrier method; or (c) 2 barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >= 1 year
Females of child bearing potential must use adequate contraception while on study and for at least 4 weeks after stopping study treatment; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) 2 barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); females of non-childbearing potential are those who are postmenopausal greater than 1 year (naturally; not chemotherapy induced) or who have had a bilateral tubal ligation or hysterectomy
Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; two acceptable methods of birth control thus include the following: condom (barrier method of contraception) AND one of the following is required:\r\n* Established use of oral, or injected or implanted hormonal method of contraception by the female partner\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner\r\n* Additional barrier method: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel film/cream/suppository by the female partner\r\n* Tubal ligation in the female partner\r\n* Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after the last dose of study treatment; highly effective contraception methods include: \r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following: \r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Men or women of childbearing potential who refuse to use an adequate measure of contraception (oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly) unless they have past medical history of surgical sterilization
Patients with reproductive potential must use an adequate contraceptive method (e.g. abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include: birth control pills, shots, implants (placed under the skin by a health care provider) or patches (placed on the skin); intrauterine devices (IUDs); condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Patient is NOT pregnant or breast-feeding; fertile patient MUST agree to use contraception during and for 12 months after T cell infusion\r\n* Highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study patients, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following (both):\r\n*** Hormonal contraception (oral or injected) or placement of an intrauterine device (IUD) or an intrauterine system (IUS)\r\n*** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom); a condom is required to be used also by vasectomized men in order to prevent delivery of the study treatment via seminal fluid
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for four months following the last dose
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and agree to continue for 3 months after the last dose of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\nIn case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\nWomen are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
All female subjects of child bearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception; examples of adequate methods of contraception include abstinence, intrauterine device, hormonal contraception, use of spermicide and a condom by sexual partner, or partner with a vasectomy; adequate contraception must be used from the beginning of the screening period until at least 16 weeks after the last dose of KW-0761; male subjects with partners of childbearing potential must use a barrier method of contraception from the day of the first dose of KW-0761 until at least 16 weeks after the last dose
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment and for 16 additional weeks after stopping treatment; the highly effective contraception is defined as either:\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Use of a combination of any two of the following (a+b):\r\na) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\nb) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository \r\n* Oral contraception, injected or implanted hormonal methods are not allowed \r\n* Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment and for an additional 16 weeks after stopping treatment\r\n* Female partner of male study subject should use highly effective contraception during dosing of any study agent and for 16 weeks after final dose of study therapy
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Male subjects must agree to use one of the contraception methods listed below; this criterion must be followed from the time of the first dose of study medication until 4 weeks after the last dose of study medication; however, it is advised that contraception be used for a total of 16 weeks following the last dose; methods: a) abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; b) condom (during non-vaginal intercourse with any partner - male or female) OR c) condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female)
Female subjects contraception methods: a) abstinence; b) intrauterine device (IUD) or intrauterine system (IUS) that meets the < 1% failure rate as stated in the product label; c) male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; d) double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.), hysterectomy or menopause must be clinically documented
Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however WOCBP must still undergo pregnancy testing as described; investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly; at a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below: HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\r\n* Male condoms with spermicide\r\n* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject’s WOCBP partner\r\n* Nonhormonal IUDs, such as ParaGard\r\n* Tubal ligation\r\n* Vasectomy\r\n* Complete abstinence\r\n** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, profession of abstinence for entry into a clinical trial, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence; LESS EFFECTIVE METHODS OF CONTRACEPTION:\r\n* Diaphragm with spermicide\r\n* Cervical cap with spermicide\r\n* Vaginal sponge\r\n* Male condom without spermicide\r\n** A male and female condom must not be used together\r\n* Progestin only pills by WOCBP subject or male subject’s WOCBP partner\r\n* Female condom\r\n** A male and female condom must not be used together
Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study
Patients who are not willing to apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through 6 months after the final dose of study treatment; highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study patients, the vasectomized male partner should be the sole partner for that patient); OR\r\n** Use a combination of the following (both a+b): \r\n*** Placement of a non-hormonal intrauterine device (IUD) or non-hormonal intrauterine system (IUS)\r\n*** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Note: hormonal contraception methods (e.g. oral, injected, implanted) are not allowed \r\n** Note: women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment and for 4 weeks after stopping treatment\r\n* The highly effective contraception is defined as either:\r\n** True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following (a+b):\r\na) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\nb) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Oral contraception, injected or implanted hormonal methods are not allowed \r\n** Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 4 weeks after stopping treatment and for additional 12 weeks (16 weeks in total after study drug discontinuation) and should not father a child in this period\r\n** Female partner of male study subject should use highly effective contraception during dosing of any study agent and for 16 weeks after final dose of study therapy
Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the study, starting with the first dose of study drug at visit 1 through 120 days after the last dose of study drug; approved contraceptive methods include for example: intra- uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception; male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 90 days after study treatment; highly effective contraception methods include: total abstinence or male partner or female sterilization or combination of any two of the following (a+b or a+c, or b+c): a) use of oral, injected or implanted hormonal methods of contraception, b) placement of an intrauterine device (IUD) or intrauterine system (IUS), c) barrier methods of contraception: condom for male partner or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: postmenopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, a woman is considered to be of not child bearing potential only when her reproductive status has been confirmed by follow-up hormone level assessment
Female patients of childbearing potential and male patients with partners of childbearing potential who are not willing to use highly effective methods of contraception throughout the study and for 1 month after study drug discontinuation; highly effective contraception methods include: \r\n* Total abstinence or \r\n* Male or female sterilization \r\n* Combination of any two of the following: \r\n** Use of oral, injected, or implanted hormonal methods of contraception \r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Any of the following:\r\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)\r\n* Patients who are not willing to apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through 6 months after the final dose of study treatment; highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study patients, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following (both a+b):\r\n*** Placement of a non-hormonal intrauterine device (IUD) or non-hormonal intrauterine system (IUS)\r\n*** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Note: hormonal contraception methods (e.g. oral, injected, implanted) are not allowed \r\n** Note: woman are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid\r\n* Sexually active males who are unwilling to use a condom during intercourse while taking drug and for 6 months after stopping investigational medications and agree not to father a child in this period
Women of child-bearing potential and men with a female partner of child bearing potential must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and up to 4 months following completion of therapy:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 4 months following completion of therapy
If of child-bearing potential (< one year post-menopausal), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed (women only) or the time of initiation of sunitinib (sunitinib malate) (men only); both men and women must agree to continue using such precautions while receiving sunitinib or valproic acid and for 30 days after the final dose
Women of childbearing potential and men with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 90 days following the last dose of study medication or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months.
For men who are not surgically sterile, agreement to use a barrier method of contraception for >= 3 months after the last obinutuzumab dose; in addition, male patients must agree to request that their partners use an additional method of contraception, such as oral contraceptives, intrauterine device, barrier method of contraception, or spermicidal jelly
For women of reproductive potential who are not surgically sterile, agreement to use two adequate methods of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly for >= 12 months after the last obinutuzumab dose
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control (Turnstile II)
All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device [IUD]) with their partner from entry into the study through 6 months after the last dose
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
For Phase I and II: Women of childbearing potential must practice contraception. Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months. Females of childbearing potential should practice effective methods of contraception Effective methods of contraception include barrier methods (e.g., condoms, diaphragm), spermicidal jelly or foam, oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligation, and abstinence. Male patients with female partners who are of childbearing potential should also practice contraception.
Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment; one of these methods must be a condom
Female patients should not be pregnant or breast-feeding; female patients, if not postmenopausal (< 12 months of amenorrhea) or surgically sterile, should agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drugs; female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study
RECIPIENT: Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for 1 year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; women should not breast feed during the interval from study entry to one year post-transplant; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means and males who have not been sterilized by vasectomy or other means with partners who are women of child-bearing potential (WOCBP), UNLESS the women are using two birth control methods; the two methods can be a double barrier method or a barrier method plus a hormonal method; adequate barrier methods of contraception include:\r\n* Diaphragm, condom (by the partner/patient where appropriate), intrauterine device (copper or hormonal), sponge or spermicide; hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent; reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation
Women of childbearing potential must be non-pregnant and non-lactating and willing to exercise an effective form of birth control during radiation therapy (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: Condom or Occlusive cap diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Women of childbearing potential should be advised to avoid becoming pregnant while on therapy with Ruxolitinib and for 30 days after the last dose and practice effective methods of contraception. Men should be advised not to father a child while receiving treatment with Ruxolitinib and for 30 days after the last dose. Effective methods of contraception for this study include barrier methods (e.g., condoms, diaphragm); spermicidal jelly or foam; oral, depo provera, or injectable hormonal contraceptives; intrauterine devices; tubal ligation; and abstinence.
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control (Turnstile II)
Men and women of reproductive potential must agree to follow accepted birth control methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle)\r\n* A vasectomized partner\r\n* Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration\r\n* Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for at least 3 months after completion of EphA2 siRNA-DOPC therapy
Childbearing potential, including any female who has had a negative serum pregnancy test within 7 days prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; defined as follows:\r\n* Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n* Oral contraceptive, either combined or progesterone alone\r\n* Injectable progesterone\r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring\r\n* Percutaneous contraceptive patches\r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods, etc.); hysterectomy or menopause must be clinically documented
Condom (barrier method of contraception) AND
One of the following is required: i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Total abstinence from sexual relations for the duration of the treatment when applicable to the lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device or intrauterine system
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) when used with spermicidal foam, gel, film, cream, or used of a spermicidal vaginal suppository Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile.
Women who are pregnant or lactating are ineligible; women who are of child-bearing potential need to practice effective methods of contraception including oral contraceptives, intrauterine device, diaphragm with spermicides, and/or abstinence
Use of oral, injected or implanted hormonal methods of contraception or
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for 1 year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device (IUD), condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Pregnancy: Female subjects who are pregnant, lactating or have positive serum ? HCG pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
Women of childbearing age must have documentation of a negative pregnancy test and agreed that they or their partner use an effective contraceptive method such as condom/diaphragm and spermicidal foam, non-stainless-steel intrauterine device, or prescription birth control pills
Men and Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the study. Subjects who are men must also agree to use effective contraception. Note: WOCBP must be using an adequate method of contraception throughout the study and for up to 3 months after the study. Adequate methods of contraception will include (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation; pregnant and breastfeeding women will not be eligible
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control (Turnstile II)
Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.
An intrauterine device (IUD) or intrauterine system (IUS);
Do not have a vasectomized partner with confirmed azoospermia. For sites outside of the European Union (EU), it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, or the participant has changed oral hormonal contraceptive product/dose within 4 weeks prior to study drug administration, then the participant must agree to use a medically acceptable method of contraception, ie, double barrier methods of contraception such as condoms plus diaphragm or cervical/vault cap with spermicide.
Adequate contraception for women is defined as hormonal birth control or an intrauterine device (safe hormonal contraceptives include contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). In countries where two highly effective methods of contraception are required this will be an inclusion criterion.
Male and female. Males: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication. Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined Oral Contraceptive or Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches . This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Females A female subject is eligible to participate if she is not pregnant (as confirmed by a negative Urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as: 60 years old; Twelve(12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (As mentioned in study protocol) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception
If female, must be either postmenopausal, sterilised or, if sexually active, effectively practicing an acceptable method of contraception (either oral, parenteral, or implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 12 weeks (or longer as per local requirement) after the last dose of study treatment.
Negative serum or urine pregnancy test for women of childbearing potential within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible. Patients of childbearing potential must agree to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational medicinal product (IMP) and for 30 days after the final dose of IMP.
Male patients must agree to practice abstinence or use an effective barrier method of contraception during treatment and for 30-days after the last dose of carfilzomib if sexually active with a female of child-bearing potential\r\n* Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test, =< 7 days prior to registration\r\n* Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progesterone alone\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 48 hours prior to initiating treatment; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and for 5 half-lives (T1/2) (8 days) after stopping treatment; the highly effective contraception is defined as either:\r\n* True abstinence: When this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomised male partner should be the sole partner for that patient\r\n* Use of a combination of any two of the following (a+b):\r\na) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\nb) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Oral contraception, injected or implanted hormonal methods are not allowed as BKM120 potentially decreases the effectiveness of hormonal contraceptives\r\n* Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 5 T1/2 (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period
Adequate contraception is defined as hormonal birth control, intrauterine device, barrier method or total abstinence; patients who are unable or unwilling to use adequate contraception are NOT eligible
Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
Women of childbearing potential (WOCBP) must be willing to use a highly effective method of contraception (hormonal or intrauterine device [IUD] method of birth control with a failure rate of <1% when used consistently and correctly; or abstinence) for the duration of treatment with TAR-200 in combination with nivolumab plus 5 half-lives of study treatment, plus 30 days (duration of ovulatory cycle), for a total of 5 months post treatment completion. Note: WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but still must undergo pregnancy testing as described in this protocol.
In women who have not experienced menopause, negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment. Adequate forms of contraception include:\r\n* 2 adequate barrier methods\r\n* A barrier method plus a hormonal method of contraception\r\n* Abstaining from sexual activity throughout the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab.
Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of daratumumab for women)\r\n* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
Continued sexual activity in men** or women of childbearing potential*** who are unwilling to practice highly effective contraception during the study and until 6 months after the last dose of study drug (highly effective contraceptive measures include stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal ligation; vasectomy, and sexual abstinence). (**Contraception is not required for men with documented vasectomy ***Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.)
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of durvalumab and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; they must also refrain\r\nfrom egg cell donation for 180 days after the final dose of durvalumab and tremelimumab\r\n* Note: A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, copper T intrauterine device, levonorgesterel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)
Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label
Patient of childbearing potential is using either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include 2 of the following barrier methods or one barrier method combined with a hormonal contraceptive: a. intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides or condoms alone are not an acceptable method of contraception; b. male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Individuals of reproductive potential and their partners willing to practice total abstinence or use a highly effective method of contraception (failure rate < 1% per year) during treatment and for 6 months following the last dose of rucaparib; the following are allowable only:\r\n* Ongoing use of progesterone-only injectable or implantable contraceptives (eg, Depo Provera, Implanon, Nexplanon)\r\n* Placement of an intrauterine device or intrauterine system\r\n* Bilateral tubal occlusion\r\n* Sterilization, with appropriate post-vasectomy documentation of absence of sperm in ejaculate\r\n* True, complete (as opposed to periodic) abstinence
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner’s vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. A man who is sexually active with a woman of childbearing potential must always use a latex or synthetic condom during the study and for 4 months after discontinuing daratumumab
Pregnant or breastfeeding women or women of child-bearing potential who are not willing to use two highly effective methods of contraception (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence)
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for at least 8 weeks after pembrolizumab is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; acceptable forms of birth control include condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is also an acceptable form of birth control
Female participants of childbearing potential should ensure use of a highly effective method of birth control as defined by the investigator, for example, those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner during the study and for a period of at least 4 months following the last dose of any drug administered during the study
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:\r\n* Sexually active males should use a condom during intercourse while taking BYL719 and for 16 weeks after the final dose of BYL719, and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; moreover, sexually active males should not father a child for 6 months after completion of radiation per standard clinical practice\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 12 weeks after the final dose of BYL719; moreover, per standard clinical practice, women should not become pregnant for 12 months after completion of radiation; highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception]\r\n** Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); [for female study subjects, the vasectomized male partner should be the sole partner for that patient]\r\n** Use a combination of the following (both a+b):\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Note: Hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed as alpelisib may decrease the effectiveness of hormonal contraceptives\r\n* NOTE: Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago
Negative pregnancy test done =< 72 hours prior to registration for women of childbearing potential only; Note: all female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation >= 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy)\r\n* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation >= 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy); female subjects of child-bearing potential must agree to use highly effective contraception during the study treatment and for 3 months after the final dose of study treatment; female subjects exempt from this requirement are subjects who practice total abstinence; if currently abstinent, the subject must agree to use a double barrier method of contraception (i.e., condom and occlusive cap [diaphragm or cervical/vault caps]) with spermicide or until they are established on highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for 3 months after the final dose of study treatment\r\n* Highly effective contraception includes:\r\n** Placement of intrauterine device or system\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide\r\n** Vasectomized partner with confirmed azoospermia\r\n* Male subjects and their female partner who are of child-bearing potential (as defined above), and are not practicing total abstinence, must agree to use highly effective contraception during study treatment and for 3 months after the final dose of study treatment; if currently abstinent, the subject must agree to use a double barrier method of contraception if they become sexually active, or until they are established on highly effective contraception as described above
Any of the following: \r\n* Pregnant women\r\n* Nursing women \r\n* Women of childbearing potential who are unwilling to employ adequate contraception; NOTE: should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and up to 90 days following completion of therapy:\r\n** Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration) \r\n** Vasectomized male subject or vasectomized partner of female subjects\r\n** Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion\r\n** Intrauterine device (IUD)\r\n** Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n** Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy
Women of child-bearing potential (WOCBP) must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib; men must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 3 months following the last dose of abemaciclib; contraceptive methods may include an intrauterine device (IUD) or barrier method; if condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection\r\n* NOTE: women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
At a minimum, participants must agree to the use of one highly effective method of contraception as listed below:\r\n* Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly; WOCBP participants and female partners of male participants who are WOCBP are expected to use one of the highly effective methods of contraception listed below; male participants must inform their female partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner; contraception methods are as follows:\r\n** Progestogen-only hormonal contraception associated with inhibition of ovulation\r\n** Hormonal methods of contraception, including oral contraceptive pills containing combined estrogen + progesterone, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena\r\n** Nonhormonal IUDs, such as ParaGard\r\n** Bilateral tubal occlusion\r\n** Vasectomized partner with documented azoospermia 90 days after procedure\r\n*** Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success\r\n** Intrauterine hormone-releasing system (IUS)\r\n** Complete abstinence\r\n*** Complete abstinence is defined as the complete avoidance of heterosexual intercourse\r\n*** Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study treatment (plus 5 half-lives of the investigational drug plus 30 days);\r\n*** It is not necessary to use any other method of contraception when complete abstinence is elected;\r\n*** Participants who choose complete abstinence must continue to have pregnancy tests\r\n*** Acceptable alternate methods of highly effective contraception must be discussed in the event that the participant chooses to forego complete abstinence\r\n*** The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant\r\n* UNACCEPTABLE METHODS OF CONTRACEPTION\r\n** Periodic abstinence (calendar, symptothermal, post-ovulation methods)\r\n** Spermicide only\r\n** Lactation amenorrhea method (LAM)
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through 30 days after the last dose of study drug; acceptable forms of effective contraception include:\r\n* Oral, injected or implanted hormonal methods of contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n* Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* True abstinence: When this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit; a positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic ultrasound (US); a pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so
intrauterine device (IUD)
TREATMENT: Women of childbearing potential and men must agree to use highly effective contraception (see list below) prior to study entry, for the duration of study participation, and for 3 months after completion of study\r\n* Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female subjects on the study, the vasectomized male partner should be the sole partner for that subject)\r\n* Use of a combination of any two of the following (a+b or a+c or b+c):\r\n** Use of oral, injected, implanted or other hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception, women should have been stable on the oral agent before taking study treatment\r\n* Sexually active males must use a condom during intercourse
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from the day of transplant and for one week after infusion; high effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c, or b+c)\r\n** a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception women should have been stabile on the same pill for a minimum of 3 months before taking study treatment
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days following completion of therapy; for women this should include one highly effective method of contraception and one barrier method as defined below\r\n* Highly effective methods include:\r\n** Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration);\r\n** Vasectomized partner;\r\n** Medroxyprogesterone acetate depot injection;\r\n** Placement of a copper-banded intrauterine device (IUD) or intrauterine system (IUS);\r\n** Bilateral tubal ligation;\r\n* Barrier methods include:\r\n** Condom;\r\n**Occlusive cap (e.g. diaphragm or cervical/vault caps) with spermicide\r\n* Please note: use of other oral, injected or implanted hormonal methods of contraception cannot be considered highly effective as it is currently unknown whether vistusertib may reduce their effectiveness; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy
DOSE ESCALATION COHORT: Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\r\n* Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment; NOTE: acceptable forms of birth control are listed below:\r\n** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
DOSE EXPANSION COHORT: Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\r\n* Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment; NOTE: acceptable forms of birth control are listed below:\r\n** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for 30 days after tazemetostat discontinuation\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n* Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* Female subjects who use hormonal contraceptives should use an additional barrier method of birth control while on study treatment and for 30 days after discontinuation of study treatment\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
HIGHLY EFFECTIVE METHODS OF CONTRACEPTION\r\n* Male condoms with spermicide\r\n* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject’s WOCBP partner. Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\r\n* Nonhormonal IUDs, such as ParaGard\r\n* Tubal ligation\r\n* Vasectomy\r\n* Complete abstinence\r\n** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
LESS EFFECTIVE METHODS OF CONTRACEPTION\r\n* Diaphragm with spermicide\r\n* Cervical cap with spermicide\r\n* Vaginal sponge\r\n* Male Condom without spermicide\r\n* Progestin only pills by WOCBP subject or male subject’s WOCBP partner\r\n* Female Condom\r\n** A male and female condom must not be used together
Patient agrees to use acceptable form of contraception during the study and for up to 30 days after last study drug dose if female partner is of childbearing potential\r\n* Acceptable forms of contraception:\r\n** Latex condom (always used with spermicide)\r\n** Diaphragm (always used with spermicide)\r\n** Cervical cap (always used with spermicide)\r\n* Acceptable forms of secondary contraception, when used along with a barrier method:\r\n** Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. “Mini-pill”)\r\n** Tubal ligation\r\n** Partner’s vasectomy\r\n** Intrauterine device (non-progesterone T)\r\n** Vaginal sponge (containing spermicide)\r\n* Other acceptable forms:\r\n** 100% commitment to abstinence\r\n* Unacceptable forms of contraception for women of childbearing potential:\r\n** Oral contraception containing progestins only\r\n** Intrauterine device (IUD) progesterone T\r\n** Female condom\r\n** Natural family planning (rhythm method) or breastfeeding\r\n** Fertility awareness\r\n** Withdrawal\r\n** Cervical shield
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit 1 throughout the study period up to 120 days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); patients should continue contraceptive measures for 6 months from the last dose of all study medications
Female participants enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 4 weeks after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
Participant agrees to use acceptable form of contraception during the study and for up to 7 months after last study drug dose\r\n* Acceptable forms of contraception:\r\n** Latex condom (always used with spermicide)\r\n** Diaphragm (always used with spermicide)\r\n** Cervical cap (always used with spermicide)\r\n* Acceptable forms of secondary contraception, when used along with a barrier method:\r\n** Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. “Mini-pill”)\r\n** Tubal ligation\r\n** Partner’s vasectomy\r\n** Intrauterine device (non-progesterone T)\r\n** Vaginal sponge (containing spermicide)\r\n* Other acceptable forms:\r\n** 100% commitment to abstinence\r\n* Unacceptable forms of contraception for women of childbearing potential:\r\n** Oral contraception containing progestins only\r\n** Intrauterine device (IUD) progesterone T\r\n** Female condom\r\n** Natural family planning (rhythm method) or breastfeeding\r\n** Fertility awareness\r\n** Withdrawal\r\n** Cervical shield
Even women who are using oral, implanted, transdermal, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, practicing abstinence, or whose partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Sexually active fertile subjects (male and female), and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s)
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test at the baseline visit (within 7 days of the first dose of study treatment); females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after discontinuation of study treatment; the only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month before start of study treatment, hysterectomy, or bilateral oophorectomy with surgery at least 1 month before start of study treatment)
Male and female patients must agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; breastfeeding should be discontinued if the mother is treated with BKM120 and olaparib or BYL719 and olaparib; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 5 T1/2 (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation); the highly effective contraception is defined as either:\r\n** True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following:\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Oral contraception, injected or implanted hormonal methods are not allowed\r\n* Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 5 T1/2 (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period
WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI, in such a manner that the risk of pregnancy is minimized; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential \r\n* Men of fathering potential and WOCBP must be using an adequate method of contraception to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible\r\n* WOCBP are not eligible if they satisfy any of the following:\r\n** A positive pregnancy test at baseline\r\n** Pregnant or breastfeeding
Patient who is not willing to apply highly effective contraception during the study and through the duration as defined below:\r\n* Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 4 weeks after the final dose of study treatment\r\n* Highly effective contraception is defined as either:\r\n** Total abstinence: When this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following (both a+b):\r\n*** a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** b. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** c. Note: hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed as buparlisib decreases the effectiveness of hormonal contraceptives
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of tubal ligation alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening);for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* No patients with hormone receptor positive (HR+) disease should receive hormonal contraception, however the two following methods can be combined: placement of an intrauterine device (IUD) or intrauterine system (IUS) and barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Combination of any of the 2 following (a+b or a+c or b+c)\r\n** a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n*** In case of use of oral contraception, women should have been stable on the same pill before taking study treatment\r\n*** Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception \r\n*** Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Patients of childbearing potential must practice contraception; females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation; male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose; to be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or subjects must be surgically sterile
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:\r\n* Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 12 weeks after the final dose of study treatment; highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following (both a+b):\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Note: hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed\r\n* Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago\r\n* For women with therapy-induced amenorrhea, oophorectomy or serial measurements of follicle stimulating hormone (FSH) and/or estradiol are needed to ensure postmenopausal status\r\n* NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression
Acceptable methods of contraception:\r\n* Barrier methods:\r\n** Male condom plus spermicide\r\n** Copper T intrauterine device\r\n** Levonogestral-releasing intrauterine system\r\n* Hormonal methods\r\n** Implants\r\n** Hormonal shot or injection\r\n** Combined pill\r\n** Mini pill\r\n** Patch
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation; (Note: pregnant patients are excluded)
Patient with reproductive potential not willing to use an acceptable method of birth control (i.e. hormonal contraception, intrauterine device, condom or diaphragm with spermicide, or abstinence) for the duration of the study and one year post completion of therapy
Pregnant and nursing subjects may not be enrolled and pregnancy must be avoided; women of child-bearing potential—defined as a sexually active woman who has not undergone hysterectomy and who has had menses any time within the preceding 24 months—must have a negative serum or urine pregnancy test within 7 days prior to registration; women and men of childbearing potential must either commit to continued abstinence from heterosexual intercourse or commit to two acceptable methods of birth control—one highly effective method (e.g., IUD, oral or non-oral hormonal contraceptive, tubal ligation or partner’s vasectomy) and one additional effective method (e.g., latex condom, diaphragm or cervical cap) at the same time from the time of screening through final Treatment Response Assessment\r\n* NOTE: should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the subject should inform their treating phy-sician immediately\r\n* NOTE: the effects of decitabine on the developing human fetus are unknown but it is a know teratogen in mammals (mice)
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 6 months after study participation; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence; women should not breast feed while on treatment with MK-2206 and hydroxychloroquine
Patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes and continue use for 8 weeks after completing treatment; hormonal contraceptives are not acceptable as a sole method of contraception
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months of midostaurin medication; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c, or b+c):\r\na) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\nb) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\nc) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n* Sexually active males unless they use a condom during intercourse while taking drug and for 5 months after stopping midostaurin medication; they should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Female subjects must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption, 28 days prior to starting lenalidomide treatment, throughout the entire duration of study treatment including dose interruptions and 28 days after the end of study treatment.
Condom (barrier method of contraception), and 2. One of the following:
Placement of an intrauterine device (IUD) or intrauterine system (ISU)
Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (ISU) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Patients, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 8 weeks after the final dose of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment \r\n* Male partner sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of the following methods:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: Post-menopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they are:\r\n** Aged >= 60;\r\n** Or aged < 60 and have had 12 months of natural (spontaneous, in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) amenorrhea with and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range (serum FSH > 40 mIU/mL and estradiol < 10 pg/mL or according to the postmenopausal range definition for the local laboratory involved)\r\n** Or have had surgical bilateral oophorectomy (with or without hysterectomy)\r\n* For women with therapy-induced amenorrhea, oophorectomy or serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status; NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression
Female subjects in child bearing age must be using acceptable contraception methods such as hormonal contraception or two forms of barrier contraception. Acceptable contraception must be used consistently from 30 days before screening until 3 years following surgery Exclusion Criteria: Pre-operative exclusion criteria:
WOCBP must practice contraception. Acceptable methods of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligations, and abstention
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after stopping treatment; highly effective contraception methods include total abstinence, male partner sterilization (with post-vasectomy documentation of the absence of sperm in the ejaculate), or a combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception o In case of use of oral contraception, women should have been stable on the oral agent before taking study treatment\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\nWomen are considered to be physiologically capable of becoming pregnant unless:\r\n* They have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms);\r\n* They have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization\r\n** In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]; see protocol for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in the protocol) and must agree not to become pregnant or father a child while receiving treatment with study drug and for at least 3 months after completing treatment. Contraceptive measures which may be considered highly effective comprise combined hormonal contraception (oral, vaginal, or transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence, and surgically successful vasectomy. Abstinence is acceptable only if it is consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of birth control.
Women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and for 3 months for women and 6 months for men following the date of the last dose of AZD9291 and/or necitumumab:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 3 months after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 6 months following completion of therapy
Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Intrauterine device.
For women who are not postmenopausal (i.e., < 12 months after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after the last dose of study drug.
Do not agree to use a highly effective method of contraception (ie, total abstinence, [if it is their preferred and usual lifestyle], an intrauterine device or intrauterine system, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) within 30 days before study entry and throughout the entire study period and for 30 days after study drug discontinuation.
Are using oral hormonal contraceptives and who do not agree to add a barrier method. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]). For sites outside of the European Union (EU), it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, i.e. double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
Placement of an intrauterine device or intrauterine system.
Established use of oral, injected, or implanted hormonal methods of contraception or use of a barrier method of contraception.
AMKL PATIENTS: Female patients must meet at least one of the following conditions:\r\n* Must be post-menopausal for at least 1 year prior to registration (not of childbearing potential)\r\n* Must be surgically sterilized\r\n* Willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
MF PATIENTS: Female patients must meet at least one of the following conditions:\r\n* Must be post-menopausal for at least 1 year prior to registration (not of childbearing potential)\r\n* Must be surgically sterilized\r\n* Willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after ending treatment; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Total abstinence\r\n* Male/female sterilization\r\nWomen are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study
SUB-PROTOCOL AIM A: Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of child-bearing potential, who are biologically able to conceive, or men who are able to father a child, not employing two forms of highly effective contraception\r\n** Highly effective contraception (e.g., male condom with spermicide, diaphragm with spermicide, intra-uterine device, and total abstinence) must be used by both sexes during the study and must be continued for 6 months after the end of study treatment; Note: Oral, implantable, or injectable hormone contraceptives are not considered effective for this study
Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test. NOTE: FPCP is defined as premenopausal and not surgically sterilized. FPCP must agree to use maximally effective birth control or to abstain from heterosexual activity throughout the study, starting at the first dose of chemotherapy through 12 months after the infusion of cells and/or for 4 months after there is no evidence of persistence/gene modified cells in the blood, whichever is longer. Effective contraceptive methods include intra-uterine device, oral and/or injectable hormonal contraception, or 2 adequate barrier methods (e.g. diaphragm with spermicide, cervical cap with spermicide, or female condom with spermicide). Spermicides alone are not an adequate method of contraception. Or Male subjects must be surgically sterile or agrees to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential upon enrolment starting at the first dose of chemotherapy through and for 4 months thereafter or longer (if indicated in the country specific monograph/label for cyclophosphamide.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping study drug; highly effective contraception methods include:\r\n* Total abstinence or\r\n* Male or female sterilization or\r\n* Combination of any two of the following (a+b or a+c or b+c):\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Women of childbearing potential and men who are sexually active must practice reliable contraceptive measures started at least 4 weeks before study therapy and continued for at least 4 weeks following discontinuation therapy; females of childbearing potential must either completely abstain from heterosexual sexual contact or must use 2 methods of reliable contraception; reliable contraceptive methods include 1 highly effective method (intrauterine device, birth control pills, hormonal patches, injections, vaginal rings, or implants) and at least 1 additional method (condom, diaphragm, or cervical cap) every time they have sex with a male; males who are sexually active must be practicing complete abstinence or agree to a condom during sexual contact with a pregnant female or female of child bearing potential; men must agree to not donate sperm during and after the study
do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation,
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product; females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); a highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system - Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch)
Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Negative pregnancy test in females of childbearing potential (FCBP); male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 23 weeks (for females) or 31 weeks (for males) following the last dose of study medication; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner’s vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap plus spermicide; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test within 24 hours of the first study treatment
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Female subject is either: post-menopausal for at least one year before the screening visit, or surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 1 month after the last dose of alisertib
Use of oral, injected or implanted hormonal methods of contraception or;
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control
Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
Women of childbearing potential should be advised to avoid becoming pregnant with an adequate method of contraception (barrier or hormonal methods) and men should be advised to not father a child while receiving treatment with azacitidine; all men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below: women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment; men should use adequate birth control for at least 30 days after the last administration of sorafenib; post-menopausal women (defined as no menses for at least one year) and surgically sterilized women are not required to undergo a pregnancy test; females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, Depo-Provera, or injectable contraceptives, intrauterine devices, and tubal ligation; male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study
Male and female subjects of reproductive potential agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) and abstain from other methods of conception during the study and for 6 months following the study cell infusion or proof of sterility
Women of child-bearing potential and male subjects with female partners of child-bearing potential must be willing to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, or vasectomized partner) beginning before the first infusion of G-202 and for 3 months after the last infusion of G-202
Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy; however, female subjects who are post-menopausal (including those with premature menopause due to high-dose chemotherapy) are exempted from this requirement; effective methods of contraception include:\r\n* Any intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n* Hormonal (birth control pills, injections, or implants)\r\n* Vasectomized partner who is sterile prior subject enrollment and is sole sexual partner of the subject\r\n* Male subjects: latex condom during sexual contact with female of childbearing potential even if he has undergone a successful vasectomy
Subjects and their partners of reproductive potential must agree to use an effective form of contraception during the period of drug administration and for four weeks following the completion of the last administration of the study drug; an effective form of contraception is defined as oral contraceptives plus one form of barrier method or double barrier methods (condom with spermicide or condom with diaphragm)
Females of childbearing potential who are sexually active with a non-sterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); non-sterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from day 1 and for 31 weeks after receipt of the final dose of investigational product; acceptable methods of effective contraception are described in the following table: \r\n* Barrier methods: male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide\r\n* Intrauterine device methods: copper T, levonorgestrel-releasing intrauterine system (e.g. Mirena), also considered a hormonal method\r\n* Hormonal methods: implants, hormone shot or injection, combined pill, min ipilimumab ll, or patch
Female participants, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, from screening through 5 months after the last dose of study treatment (including nivolumab single agent). Approved contraceptive methods include, for example: intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condom with spermicide, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
Women of childbearing potential, be surgically sterile or agree to practice abstinence or utilize acceptable contraception (intrauterine, injectable, transdermal, or combination oral contraceptive) through 1-year post transplant; Males who are sexually active with women of childbearing potential must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) from time of screening through 12 weeks after last dose of study drug
Women of child-bearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must use one additional highly effective methods of contraception in addition to the LIUD during the study and 8 weeks after; acceptable effective contraception methods include combo of the following: a) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; b) total abstinence or; c) male/female sterilization; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation > six weeks prior to randomization
Female subjects of childbearing potential defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or who is not postmenopausal (menopause being defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes) and male patients who are not surgically sterile (vasectomy etc.), must agree to use acceptable contraceptive methods for the duration of the study and for one month after the last vaccination; acceptable forms of contraception include oral contraceptives, intrauterine device, condom or vaginal diaphragm plus spermicidal (gel/foam/cream/vaginal suppository), or total abstinence
Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to planned first dose of treatment, and agree to use dual method of contraception through 90 days after study drug treatment. Approved methods of contraception include an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner. Women of childbearing potential are defined to include any female who:
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include: \r\n* Birth control pills, shots or implants (placed under the skin by a health care provider) or patches (placed on the skin);\r\n* Intrauterine devices (IUDs); \r\n* Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of child-bearing potential must agree to use two forms of adequate contraception from time of initial consent, for the duration of study participation, and for >= 6 months after the last dose of study drug; medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B, sold for emergency use after unprotected sex, are not acceptable methods for routine use; postmenopausal woman must have been amenorrheic for at least 2 years to be considered of non-childbearing potential; sexually active men must use at least one form of adequate contraception from time of initial consent, for the duration of study participation, and for >= 6 months after the last dose of study drug
Sexually active subjects (men and women) and all subjects of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method for at least 28 days prior, throughout the avelumab treatment and for at least 60 days after avelumab treatment; highly effective methods are defined as: intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation and partner’s vasectomy; other effective methods are defined as: latex condom, diaphragm and cervical cap
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner’s vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment
Highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); NOTE: for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c, or b+c):\r\n** a) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** b) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* NOTE:\r\n** In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment\r\n** Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) OR\r\n* Sexually active males unless they use a condom during intercourse while taking drug and for 5 months after stopping midostaurin medication\r\n* NOTE:\r\n** They should not father a child in this period\r\n** A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with two effective methods of contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 120 days after discontinuation (or longer if required by local requirements) of study therapy. The two methods of contraception can either be two barrier methods or a barrier method plus a hormonal method to prevent pregnancy.
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Condom (barrier method of contraception); AND
One of the following is required: Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female subject or female partner of a male subject; Additional barrier method: contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female subject or female partner of a male subject. For male subject or male partner of female subject, vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy) performed at least 6 months before Screening. Tubal ligation in the female partner of a male subject performed at least 6 months before Screening. Established and ongoing use of oral, injected, or implanted hormonal contraceptive by female partner of a male subject.
Women of child-bearing potential (not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) must agree to use two methods of contraception, or abstain from heterosexual activity, during participation in study, from the time of consent through 120 days after the last dose of study therapy; the two methods must include at least one “barrier method”. Barrier methods are diaphragms, cervical caps, cervical shields, male condoms, and female condoms; the second method of contraception may be another barrier method, a copper containing intrauterine device (IUD), spermicidal foams, sponges and films, or hormone-based contraception (for example, hormone pills, hormone rings, hormone patches, hormone-releasing IUDs, or Depo Provera); men with partners who are capable of getting pregnant must agree to use one of  the barrier methods of contraception listed above during participation in the study, starting with the first dose of study drug through 120 days after the last dose of study therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative pregnancy test, with a serum beta-HCG with a sensitivity of 50 mIU/ml within 7 days of study treatment) or breast-feeding. In addition, a medically acceptable method of birth control must be used such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study and at least one month after the last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
If, for any reason, a woman should become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately; women who are made postmenopausal through use of GNRH agonists, and men are required to use adequate contraception for the duration of protocol treatment and for 6 months after the last dose of palbociclib and bazedoxifene; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner\r\n* Highly Effective Non-Hormonal Contraception\r\n* Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception; the following non-hormonal methods of contraception are acceptable:\r\n** True abstinence when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female patients, the vasectomized male partner should be the sole partner OR\r\n* Effective Non-Hormonal Contraception: Alternatively two of the following effective forms of contraception may be used instead:\r\n** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n** Condom with spermicidal foam/gel/film/cream/suppository\r\n** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; the use of barrier contraceptives should always be supplemented with the use of spermicide\r\n* The following should be noted:\r\n** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone; It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/ vault caps) with spermicidal foam/gel/film/cream /suppository; premenopausal women who have been on a GnRH agonist for at least 3 consecutive months prior to study entry are eligible; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment; such patients should be counseled that GnRH agonists alone may not be adequate contraception and that adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation should be employed
Pre-menopausal women must have a negative pregnancy test before study entry; both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation; acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant, double barrier and/or complete abstinence (non-periodic)
Patient agrees to use an acceptable form of contraception during the study and for up to 28 days after the last dose of Reolysin if patient or female partner is post-menarche; acceptable methods include 1) a double barrier method, such as condom and spermicide; 2) hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e., ‘mini-pill’); 3) intrauterine device (non-progesterone T); 4) surgical methods such as a bilateral tubal ligation or a vasectomy; 5) abstinence
All female patients not surgically sterile or post-menopausal (for at least 1 year) and non-vasectomized male patients must practice at least one of the following methods of birth control:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle)\r\n* A vasectomized partner\r\n* Hormonal contraceptives for at least 2 months prior to day 1 of treatment\r\n* Double-barrier method
Non-vasectomized male patients must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:\r\n* A partner who is surgically sterile or postmenopausal (for at least 1 year) or who is taking hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) for at least 3 months prior to study drug administration\r\n* Total abstinence from sexual intercourse\r\n* Double-barrier method (condom, diaphragm or cervical cup with spermicidal, contraceptive sponge, jellies, or cream)
Women of childbearing potential (WOCBP) must use method(s) of contraception for 30 days plus (+) 5 half-lives (60 days) of the study drugs; for a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required; highly effective birth control in this study is defined as a double barrier method; examples include a condom (with spermicide) in combination with a diaphragm, cervical cap, or intrauterine device (IUD); the individual methods of contraception should be determined in consultation with the investigator
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient; combination of any of the two following (a+b or a+c or b+c) a. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception b. placement of an intrauterine device (IUD) or intrauterine system (IUS) c. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill before taking study treatment; note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Women of child-bearing potential should use reliable methods of contraception from the time of screening until 6 months after discontinuing study treatment; acceptable methods of contraception include tubal ligation, tricycle combined oral or transdermal contraceptives, copper-banded intra-uterine devices and vasectomized partner; hormonal contraceptives should be combined with a barrier method of contraception; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of child-bearing potential must have a negative pregnancy test prior to entry; male patients should use reliable methods of contraception such as barrier contraception i.e. condoms during sexual activities with women of child-bearing potential and refrain from sperm donation during the trial and for a washout period of at least 6 months; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment
Patients should not become pregnant or father a baby while on this study; women should not breastfeed a baby while on this study; it is important patients understand the need to use birth control while on this study; it is not anticipated that female patients enrolling in this study will be able to conceive; however, in the rare event that this is possible, female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Males and females of childbearing potential are permitted in the study so long as they consent to avoid getting their partner pregnant or becoming pregnant, respectively, by using a highly effective contraception method, as described below, throughout the study and for up to 90 days after completion. Highly effective methods of contraception include: intra-uterine device (nonhormonal or hormonal), bilateral tubal occlusion, vasectomy, sexual abstinence, or barrier methods (e.g., condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ? 1 year. Women who have documentation of at least 12 months of spontaneous amenorrhea and have an FSH level > 40 mIU/mL will be considered postmenopausal.
Female patients must not be pregnant or breast-feeding; female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s); female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to first study procedure (leukapheresis)
Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drugs
Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills
Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug.
All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device [IUD]) with their partner from entry into the study through 6 months after the last dose
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 120 days after study discontinuation; highly effective contraception is defined as either:\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment (as described above)\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that participant\r\n* Use of a combination of any two of the following:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Appropriate hormonal contraceptives (including any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent - including oral, subcutaneous, intrauterine, or intramuscular agents)
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment: \r\n* Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 16 weeks after the final dose of study treatment; highly effective contraception is defined as either: \r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following: \r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Note: hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed\r\n* Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; women of child-bearing potential must have a negative serum pregnancy test during screening; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of AEB071 and BYL719 administration; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during dosing\r\n* Highly effective contraception methods include:\r\n** Total abstinence OR\r\n** Male or female sterilization OR\r\n** Combination the following:\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\r\n* NOTE: pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-3475\r\n* Men and nonpregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as (1) surgically sterilized, or (2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or (3) not heterosexually active for the duration of the study; the 2 birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit throughout the study period up to 120 days after the last dose of study therapy\r\n* The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study, they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period described above; if there is any question that a subject will not reliably comply with the requirements for contraception, that subject should not be entered into the study\r\n* Pregnancy: if a patient inadvertently becomes pregnant while on treatment with MK-3475, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patient’s status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within 24 hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed\r\n* Subjects who are breast-feeding are not eligible for enrollment
Women of childbearing potential (WOCBP) (including female pediatric patients who are menarcheal or who become menarcheal during the treatment), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms); highly effective methods of birth control have less than 1% chance of unwanted pregnancy during one year, if used appropriately according to the instruction of the manufacturer; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); or other forms of hormonal contraception that have comparable efficacy; in case of use of oral contraception women should have been stable on the oral agent for a minimum of 3 months before taking everolimus\r\n* Total abstinence or; male partner sterilization; (the vasectomized male partner should be the sole partner for that subject)\r\n* Female sterilization; have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Men or women of childbearing potential who refuse to use an adequate measure of contraception (oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly) unless they have past medical history of surgical sterilization
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 4 weeks (5 T1/2) (after stopping treatment); the highly effective contraception is defined as either:\r\n** True abstinence: When this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomised male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following (a+b):\r\n*** a) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** b) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Oral contraception, injected or implanted hormonal methods are not allowed\r\n* Fertile males, defined as all males physiologically capable of conceiving offspring must use condoms during treatment, for 4 weeks (5 T1/2) after stopping treatment and for an additional 12 weeks (16 weeks in total after study drug discontinuation) and should not father a child in this period\r\n* Female partner of male study subject should use highly effective contraception during dosing of any study agent and for 16 weeks after final dose of study therapy
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening; male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Effective contraception: female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; female patients who are of non-reproductive potential include the following: post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy); female patients of childbearing potential must have a negative serum pregnancy test upon study entry; male and female patients who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Men must agree to use adequate contraception (abstinence, vasectomy, or female partner use of intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation) prior to study entry and for up to one month after the last vaccination
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 6 months after; hormonal contraception methods (e.g. oral, injected, implanted) are not allowed; highly effective contraception methods include combination of any two of the following: a) placement of a non-hormonal intrauterine device (IUD) or non-hormonal intrauterine system (IUS); b) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; c) total abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); or d) male/female sterilization; (sterilization: patient has had surgical bilateral oophorectomy [with or without hysterectomy] or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; male partner sterilization [with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate]; [for female study patients, the vasectomized male partner should be the sole partner for that patient]); women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception during the study and through 20 months after the final dose of study treatment if female, and for 6 months after final dose of study treatment if male\r\n* NOTE: adequate contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study patients, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following:\r\n*** Placement of a non-hormonal intrauterine device (IUD) or non-hormonal intrauterine system (IUS)\r\n*** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n**** Note: hormonal contraception methods (e.g. oral, injected, implanted) are not allowed as it cannot be ruled out that the study drug decreases the effectiveness of hormonal contraception \r\n**** Note: women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n**** Note: male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Male patients whose sexual partner(s) are women of child-bearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child]bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include: a) surgical sterilization (subject and/or subject's partner), b) approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot), c) barrier methods (such as a condom or diaphragm) used with a spermicide, and d) an intrauterine device (IUD).
If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
If, for any reason, a woman should become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men are required to use adequate contraception for the duration of protocol treatment and for 6 months after the last dose of palbociclib; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner\r\n* Highly Effective Non-Hormonal Contraception; methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception\r\n* The following non-hormonal methods of contraception are acceptable:\r\n** True abstinence when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female patients, the vasectomized male partner should be the sole partner OR\r\n* Effective Non-Hormonal Contraception; alternatively two of the following effective forms of contraception may be used instead:\r\n** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n** Condom with spermicidal foam/gel/film/cream/suppository\r\n** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; the use of barrier contraceptives should always be supplemented with the use of spermicide; the following should be noted:\r\n*** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception; therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n*** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone\r\n* It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream /suppository
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not eligible for participation UNLESS they agree to use highly effective methods of contraception during dosing and for 5 weeks after study drugs discontinuation; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 5 weeks before receiving study treatment; in case of oophorectomy alone, the reproductive status of the woman must have been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of the following:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Note: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception, as BYL719 has not been characterized with respect to its potential to interfere with the PK and/or the effectiveness of OCs
Participants of child-bearing or child-fathering potential must be willing to use a medically effective form of birth control, which includes abstinence, while taking vandetanib and for 3 months after the last dose; female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign the informed consent form [ICF]) and for 3 months after the last dose of vandetanib to prevent pregnancy; in addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed; oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used
Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign the ICF) and for 3 months after the last dose of vandetanib to prevent pregnancy in a partner
Subject is practicing an acceptable method of contraception; female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: complete abstinence from intercourse; intrauterine device (IUD); two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); male partner is sterile prior to entry into the study and is the only partner of the female; systemic contraceptives (combined or progesterone only)
All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device [IUDC] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter; male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter; female subjects should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives
Women of childbearing age must provide a negative pregnancy test within the screening period and must be using adequate contraception (oral or injectable [depot] estrogen and/or progesterone, or intrauterine contraceptive device or double barrier method [e.g., condom and diaphragm or spermicidal gel]); non-child bearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before clinical trial start
Condom (barrier method of contraception), AND
Established use of oral, injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository).
All women of childbearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, Depo-Provera, permanent sterilization of patient or partner or total abstinence
Female patients of childbearing potential [defined as all female patients ? 12 years old or who have reached menarche, whichever occurs first] must have both of the following: a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication or for a longer period if required by regulations. i. True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. ii. Acceptable contraceptive methods include: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method. b. Have negative serum pregnancy test result at screening confirmed by negative urine pregnancy dipstick within 72 hours prior to first dose of Investigational Product (IP) (if serum test occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25 mIU/mL.
Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence.
Established use of oral, injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Throughout study, male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration or per local guidelines where these require additional description of contraceptive methods; two acceptable methods of birth control thus include the following:\r\n* Condom (barrier method of contraception); AND\r\n* One of the following is required:\r\n** Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner\r\n** Placement of an intrauterine device or intrauterine system by the female partner\r\n** Additional barrier method: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner\r\n** Tubal ligation in the female partner\r\n** Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for > 6 months
Female patients enrolled in the study, who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit 1 through 120 days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception
Male or female patient who accepts and is able to use recognized effective contraception (oral contraceptives, intrauterine contraceptive device [IUCD], barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant.
Other study-specific criteria:\r\n* Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment;\r\n** NOTE: Acceptable forms of birth control are listed below:\r\n*** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n*** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment; if the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last avelumab treatment\r\n* Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal:\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product; oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)\r\n* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [beta-Hcg] at the baseline visit [within 7 days of the first dose of study treatment]); females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after discontinuation of study treatment; the only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month before start of study treatment, hysterectomy, or bilateral oophorectomy with surgery at least 1 month before start of study treatment); current, ongoing protocols containing pertuzumab have included continuous pregnancy monitoring during the trial and for six months after the last dose of study drug is administered; women should be warned not to become pregnant for at least six months after completion of treatment
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Male partner is sterile prior to entry into the study and is the only partner of the female; - Systemic contraceptives (combined or progesterone only).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after midostaurin medication; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject
Combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository \r\n** In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within one week prior to treatment initiation
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test at the baseline visit; females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after discontinuation of study treatment; subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy)
Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence; contraception must be used during the study
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 4 weeks (5 T1/2) (after stopping treatment); the highly effective contraception is defined as either:\r\n** True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following (a+b):\r\n*** a) Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** b) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Oral contraception, injected or implanted hormonal methods are not allowed \r\n* Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 4 weeks (5 T1/2) after stopping treatment and for additional 12 weeks (16 weeks in total after study drug discontinuation) and should not father a child in this period\r\n* Female partner of male study subject should use highly effective contraception during dosing of any study agent and for 16 weeks after final dose of study therapy
FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: \r\n* For at least 28 days before starting lenalidomide\r\n* While participating in the study; and \r\n* For at least 28 days after discontinuation from the study; the 2 methods of reliable contraception must include a highly effective method (ie, intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and an additional effective (barrier) method (ie, latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
REGISTRATION INCLUSION CRITERIA: If a woman of childbearing potential, patient must use two forms of effective contraception for a minimum of 6 months following trastuzumab; effective methods of birth control include use of established oral, injected, or implanted hormonal methods of birth control, intrauterine device (IUD), intrauterine system (IUS), and condoms
Women of childbearing potential must have a negative pregnancy test at time of screening and baseline visits and agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap)
Females of child-bearing potential: willing to use two forms of effective contraception, and to continue use for 16 weeks (4 months) post last dose of study medication; effective contraception is defined as:\r\n* An intrauterine device with a documented failure rate of less than 1% per year\r\n* Male partner sterilization prior to the female subject’s entry, and this male is the sole sexual partner for that female\r\n* Complete abstinence from sexual intercourse for 14 days prior to enrollment, throughout study treatment, and for at least 4 months after the last dose of study treatment; abstinence is only acceptable when in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods, etc) and withdrawal are not acceptable methods of contraception\r\n* Double-barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository)\r\nNote: hormonal-based methods (e.g., oral contraceptives) are not permitted as contraception; female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 4 months following the last dose of study treatment; females of non-childbearing potential are those who are postmenopausal (defined as greater than 1 year without menses with an appropriate clinical profile, e.g., age appropriate, > 45 years in the absence of hormone-replacement therapy (HRT); in questionable cases, the subject must have a follicle-stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); or who have had a bilateral tubal ligation or tubal occlusion, bilateral oophoredtomy or hysterectomy; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described from D1 of treatment, throughout the treatment period, and for 16 weeks after the last dose of study treatment; if a subject becomes pregnant during the treatment period of the study, the study treatments should be stopped immediately
Female patients of childbearing potential are required to have a negative serum pregnancy test within 14 days prior to the first dose of study medication\r\n* Females are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and for 4 months after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to study enrollment, for the duration of study participation, and for 16 weeks after completion of the last dose of study drug\r\n* Specific contraception requirements for females: female subjects of childbearing potential must not become pregnant and are required to be sexually inactive by abstinence or use contraceptive methods with a failure rate of < 1%; sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject; periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception; contraceptive methods with a failure rate of < 1% include the following: \r\n** Intrauterine device (IUD) or intrauterine system (IUS) that meets the < 1% failure rate as stated in the product label\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is patient's sole sexual partner; for this definition, \documented\ refers to the outcome of the investigator's/qualified physician designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\r\n** Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); these allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label; the investigator is responsible for ensuring subjects understand how to properly use these methods of contraception\r\n* Specific contraception requirements for males: to prevent pregnancy in a female partner or to prevent exposure of any partner to the investigational product from a male subject's semen, male subjects must use one of the following contraceptive methods during the study and for a total of 16 weeks following the last dose of study drug (based upon the lifecycle of sperm): \r\n** Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject for 14 days prior to first dose of study drug, through the dosing period, and for at least 16 weeks after the last dose of study drug; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Condom (during non-vaginal intercourse with any partner - male or female) OR \r\n** Condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment and must also use highly effective methods of contraception while enrolled in the study. The use of highly effective contraception should continue for at least 14 days after the last dose of study treatment or until the last day of TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include: a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception and male/female sterilization defined as:
Male sterilization (at least 6 months prior to screening). For female patients on the study, study participation assumes the vasectomized male partner is the sole partner for that patient or b. A combination of any two of the following (i+ii or i+iii or ii+iii): i) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository ii) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception iii) Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
If a female of childbearing potential (defined as a female who is non-menopausal or surgically sterilized), patient must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; if a male with a partner who is a female of childbearing potential, patient must agree to use an acceptable method of contraception during the entire study treatment period through 4 months after the last dose of MLN8237; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
Patients of childbearing or child fathering potential must be willing to use an acceptable method of birth control prior to study entry and for the duration of the study; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence
Women of child bearing years must have a negative pregnancy test (serum or urine) within 1 week of study entry; men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine device (IUD)
Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s)
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation \r\n** Is post-menopausal\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 7 days of registration, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. Patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment.
For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) as defined in §Appendix 7.
Women of childbearing potential are requested to use acceptable methods of birth control for the duration of the study and until persistence of the study drug is no longer detected in the patient. This may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception. It is recommended that a combination of two methods be used. Patients must have normal organ and marrow function as defined below:
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis Pharmaceuticals acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product \r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s) for Cohorts 1, 2, and 4, and for 3 months after the surgery for Cohort 3
Patient of child-bearing potential is not willing to use adequate contraceptive precautions; adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner
Female patients must be of non child-bearing potential or use effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of AVX901
Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
Men and women of reproductive potential must agree to follow accepted birth control methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study
A female is eligible to enter and participate in this study if she is of: non-childbearing potential including \r\n* Any female who has had a surgical procedure rendering her incapable of becoming pregnant\r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n* Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT; childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: \r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive \r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) \r\n** Male partner sterilization\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Patients must not be pregnant/breast feeding and must agree to practice adequate contraception (acceptable forms of birth control include condom with spermicide and/or diaphragm with spermicide, and non-barrier contraception such as tubal ligation, vasectomy, oral contraceptives, implanted levonorgestrel, vaginal hormonal contraceptive ring)
A female patient is eligible to enter and participate in the study if she is:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n ** Has had a hysterectomy, or\r\n ** Has had a bilateral oophorectomy (ovariectomy), or\r\n ** Has had a bilateral tubal ligation, or\r\n ** Is post-menopausal\r\n*** Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Patients using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has a negative serum or urine pregnancy test within 14 days prior to the first dose of study treatment and agrees to one of the following:\r\n ** An intrauterine device with a documented failure rate of less than 1% per year.\r\n ** Vasectomized partner who is sterile prior to the patient’s entry and is the sole sexual partner for that woman.\r\n ** Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, throughout the clinical trial, and for at least 21 days after the last dose of investigational product.\r\n ** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; or diaphragm with spermicide; or male condom and diaphragm.\r\n ** Oral contraceptive, either combined or progestogen alone\r\n ** Injectable progestogen\r\n ** Implants of levonorgestrel\r\n ** Estrogenic vaginal ring\r\n ** Percutaneous contraceptive patches
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception, or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Total abstinence \r\n* Male/female sterilization\r\n* Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of the investigational product; in addition, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for a minimum of 4 month following last plerixafor dose and 6 months following last bevacizumab dose \r\n* Effective birth control includes:\r\n** Birth control pills, depot progesterone, or an intrauterine device plus one barrier method\r\n** Or 2 barrier methods\r\n* Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)\r\n* Hormonal contraceptive methods are not sufficient, as information about any interaction of plerixafor with hormonal contraceptives is not known\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine pregnancy test should be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
Adults of reproductive potential must be able and agree to use appropriate contraception; double barrier contraceptives must be used throughout the trial by both sexes\r\n* Women of childbearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who have had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL (and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study; women assigned to ARMS AC and D must use highly effective contraception for 16 weeks after stopping treatment; women assigned to ARM A must continue contraceptive measures for 4 weeks after stopping treatment; women assigned to ARM B must continue contraceptive measures for 5 weeks after stopping treatment; the highly effective contraception is defined as either:\r\n** True abstinence: When this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following:\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel /film/cream/vaginal suppository
For ARMs A, C and D, oral contraception (OC), injected or implanted hormonal methods are not allowed as BKM120 and potentially decreases the effectiveness of hormonal contraceptives; for ARM B, oral contraceptives, injected or implanted hormonal methods are not allowed as the sole method of contraception, as BYL719 has not been characterized with respect to its potential to interfere with the PK and/or the effectiveness of OCs
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administered
A female is eligible to enter and participate in this study if she is of: \r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy \r\n** A bilateral oophorectomy (ovariectomy) \r\n** A bilateral tubal ligation, or \r\n** Is post-menopausal \r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L) \r\n* Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of cytochrome P450 (CYP) enzymes that metabolize estrogens and progestins; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be postmenopausal, they must use adequate contraception as defined immediately below during the trial and for 8 weeks after the last dose \r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: an intrauterine device with a documented failure rate of less than 1% per year, vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female, double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide); Note: Oral contraceptives are not reliable \r\n* Female subjects who are lactating should not be in the trial\r\n* A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study
EXPANSION COHORT ONLY: A female is eligible to enter and participate in this study if she is of: \r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy \r\n** A bilateral oophorectomy (ovariectomy) \r\n** A bilateral tubal ligation, or \r\n** Is post-menopausal \r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40  pg/mL (< 140 pmol/L) \r\n* Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of cytochrome P450 (CYP) enzymes that metabolize estrogens and progestins; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be postmenopausal, they must use adequate contraception as defined immediately below during the trial and for 8 weeks after the last dose \r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: an intrauterine device with a documented failure rate of less than 1% per year, vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female, double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide); Note: Oral contraceptives are not reliable \r\n* Female subjects who are lactating not be included in the trial \r\n* A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of non-hormonal contraception; acceptable contraception includes barrier methods (e.g., condoms or diaphragm) or intrauterine devices or IUDs (these may include low-dose hormones at the discretion of the Study Chair)
Female patients of reproductive potential, defined as not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal (see above for definition) and non-sterilized males who are sexually active with a female partner of reproductive potential must be willing to adhere to the following restrictions:\r\n* Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; it is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice\r\n* Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; not engaging in sexual activity is an acceptable practice; male patients should refrain from sperm donation throughout this period; it is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period\r\n* Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly\r\n** Barrier/intrauterine methods\r\n*** Copper T intrauterine device\r\n*** Levonorgestrel -releasing intrauterine system (e.g., Mirena); this is also considered a hormonal method\r\n** Hormonal methods\r\n*** Implants: etonogestrel-releasing implants: e.g. Implanon or Norplant\r\n*** Intravaginal: ethinylestradiol/etonogestrel releasing intravaginal devices: e.g. NuvaRing\r\n*** Injection: medroxyprogesterone injection: e.g. Depo-Provera\r\n*** Combined pill: normal and low dose combined oral contraceptive pill\r\n*** Patch: norelgestromin/ethinylestradiol releasing transdermal system: e.g. Ortho Evra\r\n*** Minipill: progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 90 days after the last dose of palbociclib if the risk of contraception exists; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner\r\n* Highly effective non-hormonal contraception\r\n** Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception\r\n** The following non-hormonal methods of contraception are acceptable:\r\n*** True abstinence when this is in line with the preferred and usual lifestyle of the participant; (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n*** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female participants, the vasectomized male partner should be the sole partner OR\r\n* Effective non-hormonal contraception\r\n** Alternatively two of the following effective forms of contraception may be used instead:\r\n*** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n*** Condom with spermicidal foam/gel/film/cream/suppository\r\n*** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n*** The use of barrier contraceptives should always be supplemented with the use of spermicide; the following should be noted:\r\n**** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception; therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n**** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone\r\n* It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Male and female subjects who agree to use highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days (females) and 90 days (males) after the last dose of study drug
intrauterine device (IUD)
If not postmenopausal or surgically sterile, study patients must be willing to practice at least one of the following methods of birth control for at least a menstrual cycle before and after study drug administration: (1) total abstinence from sexual intercourse with a male; (2) sexual intercourse with vasectomized male partner; (3) other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicide or cream); (4) use of an intrauterine contraceptive device
Female patients of childbearing potential must be willing to use birth control; the 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit 1; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Female patients of childbearing potential (WOCBP) must be willing to use birth control; the 2 birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit 1; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
If female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide
Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and two years beyond treatment completion
A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly. Acceptable methods of contraception are described in Table 4.2.1-1. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
Male subjects with partners of child-bearing potential, even if surgically sterilized (ie, status postvasectomy) must agree to abstain from sexual activity or to use 2 medically approved contraceptive measures / regimens from the time of signing the informed consent form through 3 months after the treatment period\r\n* Effective birth control includes: (a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method; or (b) 2 barrier methods; effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); for subjects using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known
Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie: a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Women of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) during and after the study (3 months after the last dose of any component of the treatment regimen)
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of any component of the treatment regimen. The exception to this restriction is that if the participant's female partner is surgically sterile, a second method of birth control is not required
Women who are pregnant or lactating are ineligible due to teratogenic effects on developing fetuses; women who are of child-bearing potential need to practice effective methods of contraception including oral contraceptives, intrauterine device, diaphragm with spermicides, and/or abstinence
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
Inclusion Criteria (Parts A and B):\n\n          1. Male or female aged at least 18 years or older, at the time of signing the informed\n             consent form.\n\n          2. The patient (or their legal representative) has provided written informed consent,\n             which signifies an agreement to enter the study and comply with the restrictions and\n             requirements listed in the informed consent form.\n\n          3. ECOG performance status ? 2\n\n          4. Life expectancy of at least 3 months\n\n          5. Patients must have measurable disease, according to RECIST 1.1 (defined as at least\n             one lesion that can be accurately measured in at least one dimension (longest diameter\n             to be recorded for non-nodal lesions and short axis for nodal lesions) as ? 20 mm (?2\n             cm) with conventional techniques or as ?10 mm (?1 cm) with spiral CT scan), or RANO\n             criteria for Glioma.\n\n          6. Patients must have received at least one prior line of therapy appropriate for their\n             tumor type and stage of disease. For glioma, patient must have received at least one\n             prior treatment with radiotherapy and temozolomide. Prior treatment of any Trk\n             inhibitor(s) is not an exclusion.\n\n          7. Adequate hematologic, hepatic and renal function as defined by the following criteria:\n\n               -  Absolute Neutrophil count ? 1.5x109\n\n               -  Platelet count ? 75,000 / mm3\n\n               -  Hemoglobin level ? 9.0 g/dL\n\n               -  Total Bilirubin level ? 1.5 X ULN\n\n               -  AST and ALT ? 3 X ULN\n\n               -  Creatinine clearance* ?50 mL/min *estimated CLcr by the Cockcroft-Gault equation\n\n          8. Women of:\n\n               1. Childbearing potential must have a negative serum pregnancy test documented\n                  within 14 days prior to enrollment, and must agree to use two adequate methods of\n                  contraception from Day 1 of the study until 3 months after the end of treatment.\n                  Acceptable forms of effective contraception include;\n\n                    -  Established use of oral, injected or implanted hormonal methods of\n                       contraception.\n\n                    -  Placement of an intrauterine device or intrauterine system.\n\n                    -  Barrier methods of contraception: condom or occlusive cap (diaphragm or\n                       cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n                    -  Male sterilization (with the appropriate post-vasectomy documentation of the\n                       absence of sperm in the ejaculate).\n\n               2. Non-childbearing potential, defined as females with a documented history of a\n                  clinically recognized procedure (e.g. hysterectomy, tubal ligation, bilateral\n                  salpingo-/oophorectomy) ; or postmenopausal defined as 12 months of spontaneous\n                  amenorrhea with follicle-stimulating hormone (FSH) >40 MlU/mL). Females on\n                  hormone replacement therapy (HRT) will be required to use one of the\n                  contraception methods in Inclusion criteria 8a or must discontinue HRT to allow\n                  confirmation of post-menopausal status prior to being enrolled in the study.\n                  Following confirmation of their post-menopausal status, they can resume HRT\n                  during the study and will not be required to use contraception.\n\n          9. A male patient is eligible to participate if he is not trying to father a child and is\n             willing to use one of the relevant contraception methods as in inclusion criterion 8a\n             from Day 1 of the study until 3 months after the end of treatment.\n\n         10. Able to swallow tablets\n\n         11. Patients must be recovered to Grade 1 from the effects (excluding alopecia) of any\n             prior therapy for their malignancies.\n\n             Additional Criterion for Part A only\n\n         12. Patients with histologically/cytologically confirmed advanced solid tumors, and\n             documented tumor progression for whom no further standard anticancer treatment is\n             available.\n\n         13. Patients must be able to comply with the protocol requirements regarding fasting, as\n             determined by the investigator (excluding patients in food assessment cohort(s)).\n\n             Additional Criteria for Part B only\n\n         14. Patients with histologically/cytologically confirmed advanced solid tumors and\n             documented tumor progression for whom no further standard anticancer treatment exists\n             or where, in the opinion of the investigator, the existing standard anticancer\n             treatment options available are not expected to provide a reasonable benefit to the\n             patient.\n\n         15. Patients must have NTRK1, NTRK2 or NTRK3 gene fusion confirmed locally prior to first\n             dose.\n\n        Exclusion Criteria:\n\n          1. Radiotherapy within two weeks prior to study entry\n\n          2. Major surgery (excluding placement of vascular access) within 4 weeks before the first\n             dose of study treatment\n\n          3. Spinal cord compression or brain metastases unless treated and radiologically stable\n             for >6 weeks post treatment and not requiring steroids for at least 4 weeks prior to\n             start of study treatment\n\n          4. As judged by the Investigator, any evidence of severe or uncontrolled psychiatric\n             disease or systemic diseases, including history of suicide attempt or current suicidal\n             ideation or behavior, active infection including hepatitis B, hepatitis C and human\n             immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n\n          5. Concurrent treatment with another investigational agent or participated in another\n             investigational trial within 30 days of study entry\n\n          6. Diagnosed or treated for a malignancy other than the tumor under investigation in the\n             study within 5 years, or who were previously diagnosed with a malignancy other than\n             that required for the study and have any radiographic or biochemical marker evidence\n             of that malignancy. Patients with completely resected basal cell carcinoma, squamous\n             cell carcinoma of the skin, or in situ malignancy are not excluded.\n\n          7. Clinically significant cardiovascular disease, including:\n\n               -  History of myocardial infarction, acute coronary syndromes (including unstable\n                  angina), or coronary angioplasty/stenting/bypass grafting within the past 6\n                  months.\n\n               -  History of Class III or IV heart failure as defined by the New York Heart\n                  Association (NYHA) functional classification system\n\n               -  Severe cardiac arrhythmia requiring medication or other severe conduction\n                  abnormalities (e.g. clinically significant QT prolongation or Torsade de pointes)\n\n               -  Uncontrolled hypertension\n\n               -  Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy,\n                  or cardiomyopathy\n\n          8. QT prolongation defined as a QTcF interval >470 msec or other significant ECG\n             abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia\n             (ventricular rate <50 beats/min) on 12-lead ECG at screening\n\n          9. Serious concurrent medical conditions, including serious active infection, in the\n             opinion of the investigator\n\n         10. Female patients who are pregnant or breast feeding
Established intrauterine device or intrauterine system.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Female subjects must be:\r\n* Post-menopausal for at least one year before the screening visit, or\r\n* Surgically sterilized, or\r\n* Willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Condom (barrier method of contraception even if having sex with a pregnant woman)
Established use of oral, injected, or implanted hormonal method of contraception by the female partner
Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner
Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following: \r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
For male subjects, the subject must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of BAX69
Condom (barrier method of contraception) AND
Established use of oral, injected, or implanted hormonal method of contraception by the female partner performed at least 6 months before screening;
Placement of an intrauterine device or intrauterine system by the female partner;
Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner;
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Women of childbearing potential must practice contraception; females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation; male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods during the study
For female patients on the study, the vasectomized male partner should be the sole partner for that patient; combination of any of the two following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception \r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** In case of use of oral contraception, women should have been stable on the same pill before taking study treatment; Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females) during the trial and for at least three months after end of active therapy (contraception in patients with preserved reproductive capacity, patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years)
Male and female subjects of reproductive potential agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug.
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL (for US only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through 20 months after the final dose of study treatment; for males with partners with childbearing potential, highly effective contraception is required for 6 months; the highly effective contraception is defined as either:\r\n** True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient\r\n** Use of a combination of any two of the following (a+b):\r\n*** a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** b. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Oral contraception, injected or implanted hormonal methods are not allowed\r\n* Fertile males, must use highly effective (double barrier) methods of contraception (eg, spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid; female partner of male study subject should use highly effective contraception during dosing of any study agent and for 16 weeks after final dose of study therapy\r\n* Note: hormonal contraception methods (eg, oral, injected, implanted) are not allowed\r\n* Note: woman are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with ipilimumab or dabrafenib; patients should agree to use an appropriate method of birth control while on study; examples of adequate forms of birth control for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
Women of childbearing potential and men must be surgically sterilized, practicing abstinence, or agree to use 2 birth control methods prior to study entry and for the duration of study participation including up to 30 days after the last dose of MK-1775; the 2 methods of birth control can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy; the following are considered adequate barrier methods of contraception: diaphragm or sponge, and condom; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
Women of childbearing potential must have negative urine pregnancy test. Sexually active women must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes IUD plus one barrier method; on stable doses of hormonal contraception for at least 3 months plus one barrier method; 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides; or vasectomized partner
Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; women who use oral, implanted or injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
If female and of childbearing potential, or if male, agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 3 months after the completion of the study; male subject agrees to use an acceptable method for contraception for the duration of the study and for 3 months after the completion of the study
Sexually active women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy; WOCBP must have a negative serum or urine pregnancy test within 72 hours before the start of the investigational product; highly effective contraception methods include:\r\n* (a) Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* (b) Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* (c) Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of any two of the following (a+b or a+c or b+c)\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and >= 12 months after the last dose of obinutuzumab for women, and 3 months after the last dose of obinutuzumab for men
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
Female patients of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
Patient of childbearing potential (defined by the clinical sites' standards) is using adequate birth control measures (e.g., barrier method with spermicide; intrauterine device; implantable or injectable hormonal contraceptives; surgical sterilization) for the duration of the study and will continue to use such precautions for 12 months after receiving treatment.
Females of childbearing potential must be willing to abstain from heterosexual activity or to use two effective methods of contraception from the time of informed consent until 4 months after the last dose of mirvetuximab soravtansine\r\n* Medically acceptable contraceptives include:\r\n** Surgical sterilization (such as a tubal ligation or hysterectomy)\r\n** Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)\r\n** Barrier methods (such as a condom or diaphragm) used with a spermicide\r\n** An intrauterine device (IUD)\r\n* Contraceptive measures such as Plan B are not acceptable
Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication if of childbearing potential as defined in this protocol. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable method of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), cooper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
Female patient of child-bearing potential or male patient with partner of child-bearing potential but unable or unwilling to use effective contraception (double barrier such as condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream; or hormonal method such as oral, parenteral or transdermal hormonal agents for at least three months prior to study drug administration)
Women of childbearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period. Adequate contraception includes intra-uterine device, barrier methods with spermicide, or oral contraceptives (unless clinically contraindicated for the subject population or per local practice, refer to protocol for further details)
Double barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Oral*/ injected/ implanted/ transdermal hormonal contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), e.g., hormone vaginal ring.
Female subjects are eligible to enter the study if they are either:\r\n* Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n** Has had a hysterectomy, or\r\n** Has had a bilateral oophorectomy (ovariectomy), or\r\n** Has had a bilateral tubal ligation, or\r\n** Is post-menopausal (demonstrates total cessation of menses for greater than or equal to 1 year)\r\nOR\r\n* Of childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following contraceptives\r\n** An intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n** Vasectomized partner who is sterile prior to the subject’s entry and is the sole sexual partner for that woman\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, during the clinical trial, and for at least 14 days after the last dose of investigational product\r\n** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm
Sexually active women of childbearing potential must commit to 2 methods of contraception while enrolled on the trial and continue using contraceptives for at least 7 months post study drug administration; sexually active men must commit to 1 method of contraception while enrolled and for 7 months after; hormonal contraceptives such as birth control pills, patches, implants or injections are not allowed in patients who are hormone receptor (HR) positive (+)
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
Agrees to use a medically effective method of contraception. Male subjects and women of child-bearing potential (WOCBP) must agree to use effective contraception, e.g., oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide), or practice true abstinence from sexual intercourse during the study and for 3 months after the last dose. Women of child-bearing potential include female subjects who have experienced menarche and have not undergone surgical sterilization or are not postmenopausal (defined as amenorrhea ? 12 consecutive months without an alternative medical cause);
Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening; male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Negative pregnancy test in females of childbearing potential (FCBP); male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner’s vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-study visit through 120 days after the last dose of trial treatment; breastfeeding should be discontinued if the mother is treated with MK-3475\r\n* Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from the time of the pre-study visit, through the course of the study and for 120 days after the last dose of study medication; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period; if there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study\r\n* If a patient inadvertently becomes pregnant while on treatment with MK-3475, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patient’s status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within 24 hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed
Women of child-bearing potential must have a negative serum pregnancy test and agree to remain sexually abstinent, have a partner who is sterile (i.e., vasectomy), or use two medically effective methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device (IUD));
Patient with reproductive potential (female and male) who do not agree to use an accepted effective method of contraception (hormonal or barrier methods, abstinence) during the study treatment period and for at least 3 months following completion of study treatment; for female patient enrolled, the following methods of contraception are acceptable: oral contraceptives accompanied by the use of a second method of contraception, or intra uterine device (IUD) or women who are surgically sterile, or women who are post –menopausal or other reasons have no chance of becoming pregnant
Surgically or biologically sterile or willing to practice acceptable birth control, as follows:\r\n* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of day 1 of study treatment; women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence\r\n* Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, IUD, transdermal/implanted or injected contraceptives, and abstinence
Women must not be able to become pregnant (e.g., post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted participants for 18 months after the first dose of study therapy; for the first 60 days post-transplant, recipients should be encouraged to use non-hormonal contraceptives; if using a barrier method, a double barrier method should be used
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. A barrier method of contraception must be employed by all subjects (male and female), regardless of other methods.
A female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment; sexually active pre-menopausal female subjects (and male subjects whose sexual partners are of childbearing potential) must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
The following patients will be excluded from this study:\r\n* Pregnant women\r\n* Breastfeeding women\r\n* Men or women who are sexually active and unwilling to use a medically acceptable method of contraception (e.g., such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 6 months after end of active therapy; a highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least 2 years
Highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g. male condom, female condom, or diaphragm with spermicidal get) during the course of the study and for 4 months after the last dose of study drug(s) even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control
intrauterine device (IUD);
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Men of reproductive potential and their female partners must use highly effective contraception during treatment, for 5 half-lives (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period; the highly effective contraception is defined as either:\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Sterilization: female partners have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male participant sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* Use of a combination of any two of the following (a+b):\r\n** a) Female partner with prior placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** b) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Oral contraception use by female partners, injected or implanted hormonal methods are not allowed as BKM120 potentially decreases the effectiveness of hormonal contraceptives\r\n** Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 5 T1/2 (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period
Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception; highly effective barrier contraception must be used throughout the trial and 8 weeks after the last dose of study drug (e.g. male condom with spermicidal diaphragm with spermicide; intra-uterine device); oral, interactions are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 14 days prior to starting study drug
Women of childbearing potential must commit to using a double barrier method of contraception, an intrauterine device, or sexual abstinence for the duration of the study and for at least three months after study completion
Agree to use a double-barrier method of contraception which involves the use of a condom in combination with one of the following: contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam, if having sex with a woman of child-bearing potential during the length of the study and for one week after abiraterone is discontinued and for at least three months after enzalutamide is discontinued
Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ?18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 4 months after the last study treatment; highly effective contraception methods include the following:\r\n* Total abstinence\r\n* Male or female sterilization\r\n* Combination of any two of the following:\r\n** Use of oral, injected, or implanted hormonal methods of contraception\r\n** Placement of an intrauterine (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to initiation of the study; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilisation if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).
If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Placement of intrauterine device or system,
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide,
Female patients must be one year post-menopausal, surgically sterile, or using an acceptable method of contraception during and continued after the last dose of study medications (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation); male patients must be surgically sterile or using an acceptable method of contraception during their participation in this study; contraceptive use will continue for at least two months after the last dose of study medication
Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose. (Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is the sole partner for a female subject. The double barrier method can be used in regions where considered acceptable and adequate, defined as condom or occlusive cap plus spermicidal agent).
Female subjects of childbearing potential (Female subjects who are not surgically sterilized, not at least 1 year postmenopausal) must agree to use adequate contraception (e.g. intrauterine device (IUD), condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: during the study and for at least 1 month prior to drug administration and for 4 months after treatment. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the Study.
Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n* An intrauterine device with a documented failure rate of less than 1% per year\r\n* Vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female\r\n* Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n* Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide)\r\n* Note: oral contraceptives are not reliable due to potential drug-drug interactions
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nab-paclitaxel through 28 days after the last dose; men should be advised to not father a child while receiving treatment with nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
Pregnant or lactating; patients of childbearing potential must use an effective method of contraception from the time of study entry to at least one year post-transplant; effective methods include intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, or barrier methods (condom, diaphragm, or cervical cap); males on the protocol, and their partners of child-bearing potential, must also use an effective form of contraception at study entry and for one year post-transplant; women should not breastfeed during the interval from study entry to one year post-transplant
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator; male with partners of child bearing potential must practice reliable method of contraception (condoms) approved by the investigator; the patient must agree to continue use of birth control for at least 3 months after receiving last dose of study drugs
Women of childbearing potential must practice contraception; females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation; male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: (A) total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; (B) female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; (C) male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient (D) combination of any of the two following (a+b or a+c or b+c): (1) use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception (B) placement of an intrauterine device (IUD) or intrauterine system (IUS); (C) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository in case of use of oral contraception, women should have been stable on the same pill before taking study treatment; Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Before enrollment, a woman must be one of the following:\r\n* Not of childbearing potential, defined as:\r\n** Postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/mL)\r\n** Permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) \r\n** Otherwise be incapable of pregnancy\r\n* Of childbearing potential and practicing a highly effective method of birth control (consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies) during the study and for 3 months after receiving the last dose of study agent NOTE: Examples include established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidals (including foam/gel/film/cream/suppository) or occlusive cap (diaphragm or cervical/vault caps) with spermicidals; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject); Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control
Established use of oral, injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 30 days after study treatment:\r\n* Total abstinence or\r\n* Male or female sterilization or\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Post-menopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) unless they are using highly effective methods of contraception during study treatment and for 3 months following the discontinuation of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study the vasectomized male partner should be the sole partner for that patient\r\n* Combination of the following (a+b or a+c, or b+c):\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS).\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 12 months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\r\n* Combination of any of the two following (a+b or a+c or b+c)\r\n** a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n** b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** c. Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception, women should have been stable on the same pill before taking study treatment\r\n* Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception\r\n* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (defined below); highly effective contraception must be used by both sexes (female patients and their male partners) during study treatment and for 30 days after the last dose of study medication; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Combination of the following:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:\r\n* Sexually active males should use a condom during intercourse while taking drug and for 8 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 4 weeks after the final dose of study treatment\r\n* Highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study subjects, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following:\r\n*** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n*** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n*** Note: hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for 2 months after the last dose of chemotherapy; sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy
Male subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; two acceptable methods of birth control thus include the following:\r\n* Condom (barrier method of contraception); AND\r\n* One of the following is required:\r\n** Established use of oral, or injected or implanted hormonal method of contraception by the female partner\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner\r\n** Additional barrier method: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner\r\n** Tubal ligation in the female partner\r\n** Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months
If a female of childbearing potential, must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib; if a male, agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 3 months following the last dose of abemaciclib; contraceptive methods may include an intrauterine device (IUD) or barrier method; if condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection\r\n* Note: cases of pregnancy that occur during maternal exposures to abemaciclib should be reported; if a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately; data on fetal outcome and breast-feeding are collected for regulatory reporting and drug safety evaluation
Must not be pregnant or breastfeeding; female patients who are sexually active and of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients who are sexually active, effective methods of contraception must be used throughout the study and for three months following the last dose; abstinence is an acceptable form of contraception
Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as a condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation
Participants of child-bearing or child-fathering potential must agree to use adequate contraception (hormonal birth control; intrauterine device; double barrier method; or total abstinence) throughout their participation, including up until 30 days after last dose of CUDC-907
Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;\r\n* Total abstinence;\r\n* Male/female sterilization
Males and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment; all men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below:\r\n* Females of childbearing potential: recommendation is for 2 effective contraceptive methods during the study; adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation\r\n* Male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study or to abstain
Females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e.: intrauterine device [IUD] or oral contraceptives for 3 months prior to entry into the study)
Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening, including 30 days after discontinuation of the study drug) to avoid becoming pregnant or fathering a child\r\n* Females of non-childbearing potential are defined as women who (a) are equal to or greater than 55 years of age with history of amenorrhea for 1 year, or (b) are surgically sterile for at least 3 months\r\n* For females of childbearing potential, or for males, appropriate precautions are those that are at least 99% effective in preventing the occurrence of pregnancy; these methods should be communicated to the subjects and their understanding confirmed:\r\n** Complete abstinence from sexual intercourse \r\n** Double barrier methods\r\n** Condom with spermicide in conjunction with use of an intrauterine device (IUD) \r\n** Condom with spermicide in conjunction with use of a diaphragm \r\n** Oral, injectable, or implanted contraceptives\r\n** Tubal ligation or vasectomy (surgical sterilization)
At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:\r\n* HIGHLY EFFECTIVE METHODS OF CONTRACEPTION\r\n** Male condoms with spermicide\r\n** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject’s WOCBP partner\r\n** Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\r\n** IUDs, such as ParaGard\r\n** Tubal ligation\r\n** Vasectomy\r\n** Complete abstinence\r\n*** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills; a negative pregnancy test must be obtained prior to study enrollment or waiver signed
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to taking their first dose of BGB324. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for ?3 months after the last dose of BGB324. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility, including tubal ligation, or evidence of post-menopausal status defined as any of the following:
Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 3 months after the end of study treatment; women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months)
Females of childbearing potential must have a negative pregnancy test =< 28 days prior to registration; all females of childbearing potential who are sexually active, must agree to use a highly reliable method of contraception to prevent pregnancy; these include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections) \r\n* NOTE: Females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> 12 months since last menses)
Patient is practicing an acceptable method of contraception (documented in chart); female patients (or female partners of male patients) must either be non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use 1 of the following highly effective methods of contraception (i.e., Pearl Index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:\r\n* Complete abstinence from intercourse\r\n* Intrauterine device (IUD)\r\n* Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide)\r\n* Male partner is sterile prior to entry into the study and is the only partner of the female\r\n* Systemic contraceptives (combined or progesterone only)
Patients who are not willing to apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment\r\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through 6 months after the final dose of study treatment; highly effective contraception is defined as either:\r\n** Total abstinence: when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Sterilization: patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female study patients, the vasectomized male partner should be the sole partner for that patient)\r\n** Use a combination of the following (both of the following):\r\n*** Placement of a non-hormonal intrauterine device (IUD) or non-hormonal intrauterine system (IUS)\r\n*** Barrier method of contraception: condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** Note: hormonal contraception methods (e.g. oral, injected, implanted) are not allowed to count as contraception; patients are able to continue taking oral contraceptives if desired\r\n** Note: women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\r\n* Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continue using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid\r\n* Sexually active males who are unwilling to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child in this period\r\n* Patients unwilling or unable to comply with the protocol
Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continue using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid
Pregnant, unwilling to use adequate contraception during study treatment duration, had given birth, or nursed at any time during the last 12 months\r\n* All heterosexually active women who may become pregnant must agree to use a reliable nonhormonal contraceptive method during the study and for 2 months after completing study medications; reliable nonhormonal methods of contraception include barrier contraception and an intra-uterine device (IUD); [Note: Women who had tubal ligation or had a partner who had undergone a vasectomy (and are monogamous) are eligible for the study and are not required to use barrier contraception
Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation; Note:\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation\r\n* For men and women who are not postmenopausal (i.e., >= 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone [FSH], if not on hormone replacement) or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females), agreement to remain abstinent or use highly effective or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and at least through week 12 after last dose\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Examples of contraceptive methods with an expected failure rate of < 1% per year include male sterilization and hormonal implants; alternatively, proper use of combined oral or injected hormonal contraceptives and certain intrauterine devices or two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year (barrier methods must always be supplemented with the use of a spermicide)\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\r\n* Should a female partner of a male study participant become pregnant while the male participant is on study, the male participant should inform his study physician immediately
Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (eg, condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days after the last dose of the study drug for males
11. Male or female fertile patient using reliable contraceptive measures (such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized/sterilized partner, use of a double-barrier method or sexual abstinence). The patient and his/her parent(s)/legal guardians must be counseled on the importance of avoiding pregnancy before or during the study.
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Using an adequate method of contraception for at least 3 months with no changes and will remain on the contraception for the duration of the trial; an adequate method of contraception is defined as either a hormonal based method (except vaginal rings); an intrauterine device (IUD) (inserted at least 30 days prior to enrollment); female sterilization; or sexual activity with a partner who had a vasectomy
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections, (2) barrier methods (such as condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
For females of childbearing potential who are sexually active and males who have sexual contact with a female of childbearing potential: willingness to use of reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) during study participation
Women currently on hormonal contraception (i.e., oral contraceptives, Mirena intrauterine device [IUD]) are eligible to participate if they have been on a stable dose for at least 3 months; women who have undergone bilateral tubal ligation are also eligible to participate in this study; there will be stratification for hormonal contraceptive use within 3 months prior to registration
Women of child bearing potential must agree to use contraception through one menstrual cycle post end of study or if early withdrawal, through what would have been visit 11. Methods include intrauterine device or double barrier method, hormonal contraceptive in combination with a double barrier method.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Women of reproductive potential must agree to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 7 months after completing therapy; acceptable forms of primary contraception include the following: combination (levonorgestrel-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following: \r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
Female patients of reproductive potential and non-sterilized males who are sexually active with a female partner of childbearing potential must be willing to adhere to the following restrictions:\r\n* Females of reproductive potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; it is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice\r\n* Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; not engaging in sexual activity is an acceptable practice; male patients should refrain from sperm donation throughout this period; it is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period \r\n* Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly \r\n** Barrier/Intrauterine methods \r\n*** Copper T intrauterine device\r\n*** Levonorgestrel-releasing intrauterine system (e.g., Mirena)\r\n** Hormonal Methods\r\n*** Implants: Etonogestrel-releasing implants (e.g. Implanon or Norplant)\r\n*** Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g. NuvaRing\r\n*** Injection: Medroxyprogesterone injection: e.g. Depo-Provera\r\n*** Combined pill: Normal and low dose combined oral contraceptive pill\r\n*** Patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g. Ortho Evra \r\n*** Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of Study treatment • Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential; highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment; Note: while oral contraceptives are allowed, they should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction
Inclusion Criteria:\n\n        Patients eligible for inclusion in this study had to fulfill all of the following criteria:\n\n          1. Written informed consent must be obtained before any assessment was performed.\n\n          2. Male and female patients at least 18 years of age.\n\n          3. Patients weighed between 45 -120 kg to participate in the study, and had a body mass\n             index (BMI) within the range of 18 - 34 kg/m2\n\n          4. Scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood\n             transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell\n             depleted, myeloablative or non-myeloablative/reduced intensity, haploidentical) and\n             began conditioning chemotherapy within 48 hours of planned dosing day.\n\n          5. Patient seropositive for HCMV before transplantation; donor could be seropositive or\n             seronegative for HCMV (donor positive/recipient or donor negative/recipient positive).\n             Historical patient HCMV serology data collected within the last 12 months or local\n             assays could be used to qualify the patient for enrollment.\n\n          6. Able to communicate well with the investigator, to understand and comply with the\n             requirements of the study.\n\n        Exclusion Criteria:\n\n        Patients fulfilling any of the following criteria were not eligible for inclusion in this\n        study:\n\n          1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives\n             of enrollment, or until the expected PD (pharmacodynamic) effect has returned to\n             baseline, whichever is longer; or longer if required by local regulations.\n\n          2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical\n             classes.\n\n          3. Karnofsky performance score <50%.\n\n          4. Had HCMV-related organ disease within 6 months prior to enrollment.\n\n          5. Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase\n             chain reaction (PCR) assays prior to enrollment from samples collected within 14 days\n             prior to enrollment. Local assays could be used to qualify the patient for enrollment.\n\n          6. Received any of the following within 30 days prior to enrollment: ganciclovir,\n             valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3\n             gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin\n             (>500 mg/kg), or any other medication with anti-HCMV activity.\n\n          7. Required mechanical ventilation within 7 days prior to enrollment.\n\n          8. Received any vasopressors or other agents for hemodynamic support within 7 days prior\n             to enrollment. These agents included but are not limited to epinephrine, metaraminol,\n             norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.\n\n          9. Impaired renal function requiring dialysis.\n\n         10. Any surgical or medical condition which might increase the risk for thrombotic events\n             if given immunoglobulins. These conditions included cryoglobulinemia, monoclonal\n             gammopathies, and hypertriglyceridemia (fasting level >1000 mg/dL). The investigator\n             should make this determination in consideration of the subject's medical history and\n             laboratory data.\n\n         11. Severe liver disease or liver injury as indicated one or more of the following:\n\n               -  Alanine aminotransferase (ALT) >5-times the upper limit of normal (ULN).\n\n               -  Aspartate aminotransferase (AST) >5-times the upper limit of normal.\n\n               -  Gamma-glutamyl transferase (?-GT) >5-times the upper limit of normal.\n\n               -  Serum total bilirubin (TBL) >3-times the upper limit of normal.\n\n         12. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a\n             female after conception and until the termination of gestation, confirmed by a\n             positive human chorionic gonadotropin (hCG) laboratory test.\n\n         13. Women of child-bearing potential, defined as all women physiologically capable of\n             becoming pregnant, unless they were using effective methods of contraception during\n             dosing of study treatment.\n\n             Effective contraception methods included:\n\n               -  Total abstinence (when this is in line with the preferred and usual lifestyle of\n                  the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal,\n                  post-ovulation methods) and withdrawal are not acceptable methods of\n                  contraception.\n\n               -  Female sterilization (have had surgical bilateral oophorectomy with or without\n                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.\n                  In case of oophorectomy alone, only when the reproductive status of the woman was\n                  confirmed by follow up hormone level assessment.\n\n               -  Male sterilization (at least 6 months prior to screening). For female patients on\n                  the study, the vasectomized male partner should be the sole partner for that\n                  subject.\n\n               -  Barrier methods of contraception: Condom or Occlusive cap (diaphragm or\n                  cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository.\n\n               -  Use of oral, injected or implanted hormonal methods of contraception or other\n                  forms of hormonal contraception that have comparable efficacy (failure rate <\n                  1%), for example hormone vaginal ring or transdermal hormone contraception.\n\n               -  Placement of an intrauterine device (IUD) or intrauterine system (IUS). In case\n                  of use of oral contraception women would have been stable on the same pill for a\n                  minimum of 3 months before taking study treatment. Women were considered\n                  post-menopausal and not of child bearing potential if they had 12 months of\n                  natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age\n                  appropriate, history of vasomotor symptoms) or had surgical bilateral\n                  oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks\n                  ago. In the case of oophorectomy alone, only when the reproductive status of the\n                  woman had been confirmed by follow up hormone level assessment was she considered\n                  not of child bearing potential.\n\n         14. History of positive HIV (ELISA and Western blot) test result. Testing was not\n             required. No additional exclusions were applied by the investigator, in order to\n             ensure that the study population was representative of all eligible patients.
Willingness to employ adequate contraception for men and women of childbearing potential; acceptable methods include double barrier methods, intrauterine device (IUD), postmenopausal status documented by serum follicle-stimulating hormone (FSH), and/or documentation of surgical sterilization
Heterosexual women and men must agree to use TWO effective forms of birth control for the duration of study participation and for 30 days following the last dose of study medication\r\n* Men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug\r\n* The following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control:\r\n** Female with bilateral oophorectomy and/or hysterectomy\r\n** Female with fallopian tubes cut, tied, or sealed\r\n** Female with sterilization implant (e.g. Adiana, Essure) placed > 3 months prior to randomization\r\n** Female post-menopausal (> 1 year since last menses)\r\n** Male with vasectomy > 3 months prior to randomization\r\n* One of the following methods of birth control must be used by women of childbearing potential:\r\n** Combined oral contraceptive pill in continuous use for > 30 days prior to study entry\r\n** Vaginal ring (e.g. NuvaRing) in continuous use for > 30 days prior to study entry\r\n** Skin patch (e.g. Ortho Evra) in continuous use for > 30 days prior to study entry\r\n** Injection (e.g. Depo-Provera, Noristerat) in continuous use for > 30 days prior to study entry\r\n** Copper intrauterine device (IUD) (e.g. ParaGard)\r\n* Note: The following hormonal methods are NOT acceptable:\r\n** Low dose progesterone only oral contraceptive pill (“mini pills” e.g. Micronor, Nor-Q.D., Ovrette)  \r\n** Norplant subdermal implant\r\n** Mirena Hormonal Implanted Uterine Device (IUD) \r\n* In addition to the above method of contraception, one of the following methods of contraception will ALSO be used for the duration of study participation and for 30 days following the last dose of study medication: \r\n** Diaphragm, cervical cap, or cervical shield with spermicide\r\n** Contraceptive sponge (e.g. Today Sponge)\r\n** Condom (male or female type) plus spermicide
Women of childbearing potential who are not using a reliable method of contraception; methods of contraception that are considered reliable are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products; the “rhythm method” is not considered a reliable method of contraception
Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 64 Cu-anti-CD38 [daratumumab]-NHS-DOTA for women)\r\n* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception, or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those, which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
Females are eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)\r\n** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:\r\n** An intrauterine device with a documented failure rate of less than 1% per year \r\n** Vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide)\r\n** Oral contraceptives
If of childbearing potential (males and females), willing to use an effective form of contraception such as latex condom, hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter
Pre-menopausal women must have a negative pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant, double barrier and/or complete abstinence (non-periodic).
Women of child-bearing potential (WOCBP) and men able to father a child must agree to use highly effective contraception while on study drug and for 30 days after the last dose of avelumab; WOCBP must have a negative pregnancy test within 28 days of initiation of dosing; highly effective contraceptive measures include: stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomy and sexual abstinence\r\n* Contraception is not required for men with documented vasectomy\r\n* Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential\r\n* Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation
For all women of childbearing potential, a negative pregnancy test must be obtained at the baseline visit before starting study treatment\r\n* For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year; barrier methods must always be supplemented with the use of a spermicide\r\n* For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period\r\n** Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug.
Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills
Subjects of child-bearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Depo-Provera) during the study and for 90 days following the last dose of the study drug
Women of childbearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the study and for 90 days after the last dose of AZD1775; WoCBP are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the patient, tubal ligation, vasectomized partner, barrier methods (eg, cap plus spermicide, sponge plus spermicide, diaphragm plus spermicide, or male condom plus a spermicide), intrauterine device methods (eg, Copper T or Levonorgestrel-releasing intrauterine system), or hormonal methods (eg, any registered and marketed contraceptive agent that contains an oestrogen and/or a progestational agent and that is administered via the oral, subcutaneous, transdermal, intrauterine, or intramuscular route as an implant, hormone shot or injection, combined pill, minipill or patch); all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; all WoCBP must have a negative pregnancy test within 3 days prior to study the initiation of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception (contraceptive pill, or intrauterine device ((IUD)), or two mechanical barriers).
Women of child-bearing potential and men must agree to use adequate contraception prior to the study entry, for the duration of study participation and up to 12 weeks following completion of therapy\r\n* Acceptable contraception includes:\r\n** Total abstinence from sexual intercourse \r\n** Surgically sterilized subject or partner (i.e. male vasectomy, tubal ligation, female hysterectomy or bilateral oophorectomy)\r\n** Use of 2 of the following:\r\n*** Barrier methods: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide\r\n*** Hormonal contraception (pills, patch, intrauterine device, or injections)
Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after discontinuation of study treatment.
Women of childbearing potential must have a negative serum or urine pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and/or double barrier.
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to enrolling. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
The patient must take precautions to not become pregnant or produce offspring. Women must be of non-childbearing potential (surgically sterile or postmenopausal for at least 12 months, confirmed by follicle-stimulating hormone [FSH] >40 IU/L) or agree to use a medically accepted method of contraception for the duration of the study and 90 days after treatment. Men must be surgically sterile or agree to use a medically accepted method of contraception for the duration of the study and 90 days after treatment. Acceptable methods of contraception include abstinence, barrier method with spermicide (excluding cervical cap and sponge), intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
Women of childbearing potential must agree to use acceptable methods of birth control starting with the screening visit and up to 120 days after the last dose of study treatment. Recommendation is for 2 effective contraceptive methods during the study. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation.
Heterosexually active males and their partners of childbearing potential must agree or use at least 2 forms of highly effective methods of contraception, including at least 1 barrier method. Highly effective methods of contraception are those that, alone or in combination, result in a failure rate of <1% per year when used consistently and correctly (i.e., perfect use). Contraception must include male condom or female condom used with a spermicide (i.e., foam, gel, film, cream, suppository) as well as established use of oral, injected or implanted hormonal methods of contraception, correctly placed intrauterine device or intrauterine system.
Established use of oral, injected or implanted hormonal methods of contraception
Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.