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
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.
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
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
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
Double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide
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
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.
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
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
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
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
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
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
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.
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
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) 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.
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
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
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
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
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)
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
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
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
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
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
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
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)
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
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 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
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
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
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)
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
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
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, 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
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.
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
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)
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)
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
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 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
Subjects must use 2 forms of highly effective contraception concomitantly from the initiation of study therapy until 6 months after the last dose of study therapy; additionally, the use of condoms is required; it should also be noted that, where 2 forms of effective contraception are required, a subject may choose to use a double-barrier method consisting of condom and cervical occlusive cap / diaphragm with spermicide
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
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.
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.
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,
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)
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.
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:
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
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
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.
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)
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
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)
barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
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).
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 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)
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).
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)
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)
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
Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug; an effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm)
Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug, an effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm)
Use of highly effective contraception (females) or male condom plus spermicide (males).
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).
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);
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.
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 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
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
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
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)
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
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 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
Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 130 days after last dose of Study treatment • Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success.
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 (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
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)