Women of childbearing potential (?12 months of non-therapy-induced amenorrhea or surgically sterile) must have had a negative serum pregnancy test within the past 21 days and must use a birth control method in addition to barrier methods (condoms).
Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit 1 throughout the study period up to 120 days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Men who are sterile OR agree to use at least two forms of a reliable and highly effective method of birth control and to not donate sperm and for at least 180 days following last dose of TRC105 or sorafenib.
Sexually active male or female must be surgically sterile post-menopausal, or must agree to use a physician-approved method of birth control during the study through a minimum of 120 days after the last study drug administration.
Female patients with negative pregnancy test at Screening and use of acceptable method of birth control for study duration, unless surgically sterile or postmenopausal for at least 1 year prior to Screening.
Female patients who are not surgically sterile or postmenopausal (for at least 1 year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:
Non-vasectomized male patients must comply with at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:
Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle; cessation of birth control after this point should be discussed with a responsible physician; investigator will discuss with patient on the above points and the patient agreement will be documented in the source document; the investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol; in case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle
Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or who commits to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last dose of study treatment.
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study.
If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
Female subjects must not be pregnant; willing to use 2 methods of birth control/abstinence if applicable through 120 days after the last dose of study drug
Patient is a female of childbearing potential (FCBP)* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within 24 hours before surgery.
Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 20 weeks after the last dose of study treatments
Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study; if abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide)
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patient’s underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA) 150 mg intramuscularly (IM) or 104 mg/0.65 mL for subcutaneous (SC) injection; injection needs to be repeated every 3 months while on study; prior to IM injection, ensure that platelet count is > 30,000 x 10^9/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
if male (and whether or not surgically or medically sterile), agree to use during the study and for at least one month after the last dose of study drug a double barrier method of birth control (in addition to any other birth control method practiced by his partner) while engaging in sexual intercourse with a partner who is pregnant, possibly pregnant or able to become pregnant.
Non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from study day 1 throughout the study period up to 120 days after the last dose of study therapy
Sexually active male and female patients should use effective birth control (abstinence; hormonal or barrier method) for the duration of the study and at least 2 months from last dose.
Women of childbearing potential and men who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use 2 birth control methods before study entry, for the duration of study participation, and for 20 weeks after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Women of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Two methods of contraception which are considered accurate per protocol must be combined. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control
Patients with reproductive potential must be willing to use, in combination with her partner, 2 acceptable methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after study duration; subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g., history of vasectomy) are not required to use additional contraceptive measures
Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
Patients of childbearing potential (women who are postmenopausal for < 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject’s entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the 1st dose, if more than 7 days prior, a urine pregnancy test must be performed before the 1st dose. The female subject must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study IP administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods.
Male subjects who are willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last IP administration.
PRIOR TO CELL PROCUREMENT: Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; WOCBP patients will also be instructed to tell their male partners to use a condom\r\n* Postmenopausal status must be confirmed with documentation of absence of menses for > 1 year
PRIOR TO LYMPHODEPLETION: Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; WOCBP patients will also be instructed to tell their male partners to use a condom; post-menopausal status must be confirmed with documentation of absence of menses for > 1 year
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; WOCBP patients will also be instructed to tell their male partners to use a condom; post-menopausal status must be confirmed with documentation of absence of menses for > 1 year
commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ? 1%. without interruption from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are:
Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit and continue throughout study mandated treatment and for 90 days after the final dose of study drug; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Fertile male subjects must agree to use a medically acceptable contraceptive method (allowed methods of birth control include vasectomy or condom with spermicide) during the trial and for a period of at least 6 months following the last administration of trial drugs
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patient’s underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA) 150 mg intramuscularly (IM) or 104 mg/0.65 mL for subcutaneous (SC) injection; injection needs to be repeated every 3 months while on study; prior to IM injection, ensure that platelet count is > 30,000 x 10^9/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use at least two forms of a reliable and highly effective method of birth control and to not donate sperm and for at least 180 days following last dose of TRC105, bevacizumab, paclitaxel, and/or carboplatin
Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Female patients of any ethnic group; female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence)
In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
Sexually abstinent or correct and consistent use of one of the following methods of birth control in addition to a male partner using a condom from Screening to 3 months after the last dose of study drug:
vasectomy in male partner. Male patients must agree to sexual abstinence or to consistently and correctly use a condom in combination with one of the above methods of birth control from Screening to 3 months after the last dose of study drug.
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Female of childbearing potential (less than 12 months post-menopausal) or male with a partner of childbearing potential either agrees to be abstinent or uses a medically acceptable form of birth control during the study and for a period of 1 year after if on Arm 1
Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit 1 throughout the study period up to 120 days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); patients should continue contraceptive measures for 6 months from the last dose of all study medications
Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible
Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies
The participant, if male, is sterile or agrees to use a reliable method of birth control.
The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab
For men and women of child-producing potential, willingness to use effective contraceptive methods during the study. If female (or female partner of male patient), was either not of childbearing potential (defined as postmenopausal for ? 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing one of the following medically acceptable methods of birth control and agreed to continue with the regimen throughout the duration of the study:
Male or female patients. Women of childbearing potential must agree to use highly effective methods of birth control during the trial and for at least 1 year after the last dose of BI 836826 and 1 month after the last dose of ibrutinib.
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures during the course of the trial and for at least one month after discontinuing study drug.
Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ?55 years or 12 months if >55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are outlined in the protocol.
Female participants must be either surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or agree to use a medically effective means of birth control (hormonal or barrier method of birth control; abstinence) prior to study entry and throughout their participation in the treatment phase of this study; female participants of child bearing potential must also have a negative serum pregnancy test within 2 weeks prior to registration
Female subjects and their male partners must agree must agree to use a highly reliable method of birth control
Female subject is either post-menopausal or surgically sterilized; females of childbearing potential must have a negative serum pregnancy test within 48 hours prior to prescribing bendamustine and must commit to continued abstinence from heterosexual intercourse or use TWO acceptable methods of birth control (at least one barrier method) AT THE SAME TIME during the study and for 6 months after the last study drug; sexually active males must use a medically acceptable form of birth control for the duration of the study and for 6 months after last dose of drug
Female is not breastfeeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use 2 acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
Sexually active male subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control from Screening through 3 months after the last dose of study drug. * Two acceptable methods of birth control are as follows:
All female patients not surgically sterile or post-menopausal (for at least 1 year) and non-vasectomized male patients must practice at least one of the following methods of birth control:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle)\r\n* A vasectomized partner\r\n* Hormonal contraceptives for at least 2 months prior to day 1 of treatment\r\n* Double-barrier method
Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\r\n* NOTE: pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-3475\r\n* Men and nonpregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as (1) surgically sterilized, or (2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or (3) not heterosexually active for the duration of the study; the 2 birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit throughout the study period up to 120 days after the last dose of study therapy\r\n* The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study, they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period described above; if there is any question that a subject will not reliably comply with the requirements for contraception, that subject should not be entered into the study\r\n* Pregnancy: if a patient inadvertently becomes pregnant while on treatment with MK-3475, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patient’s status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within 24 hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed\r\n* Subjects who are breast-feeding are not eligible for enrollment
Male and female subjects who are not surgically sterile or post-menopausal must agree to use reliable methods of birth control for the duration of the study and for 90 days after the last dose of study drug administration; male partners of female subjects should use condoms for the duration of the study, and for 90 days after the last dose of study drug administration
Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign the ICF) and for 3 months after the last dose of vandetanib to prevent pregnancy in a partner
Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
Female subjects of child-bearing potential and male subjects with partners of child-bearing potential must agree to use an effective means of birth control while on study therapy and for a minimum of 4 months following last plerixafor dose and 6 months following last bevacizumab dose\r\n* Effective birth control includes:\r\n** Birth control pills, depot progesterone, or an intrauterine device plus one barrier method\r\n** or 2 barrier methods\r\n* Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)\r\n* Hormonal contraceptive methods are not sufficient, as information about any interaction of plerixafor with hormonal contraceptives is not known\r\n* Men or women of child-bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy (noted above) for the entire study period and for up to 2 weeks after the last dose of study drug are excluded from this study
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
consistent and correct use of 1 of the following highly effective methods of birth control for one month prior to the start of the study agent and 6 months after the last dose:
If female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide
Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.
In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 3 months after the last dose of study treatment in such a manner that the risk of pregnancy for a partner is minimized.
Female parents of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile.
The patient, if female and of child bearing potential, must be postmenopausal or surgically sterile, or on one of the following methods of birth control for a minimum of 2 months prior to entry into this study and throughout the duration of the study: intrauterine device (IUD), oral contraceptives, or Depo-Provera; this criteria can be waved at the discretion of the investigator if the patient’s intracranial tumor is considered life threatening and the 2 month wait required is not in the best interest of the patient; in this case, the patient must be on a reliable form of birth control as stated above
Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy) while on crenolanib and for 3 months following the last dose of crenolanib. Hormonal contraception alone is not an acceptable method of birth control for the purpose of this trial.
Male and female subjects must agree to use a highly reliable method of birth control for the duration of the study.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-study visit through 120 days after the last dose of trial treatment; breastfeeding should be discontinued if the mother is treated with MK-3475\r\n* Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from the time of the pre-study visit, through the course of the study and for 120 days after the last dose of study medication; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period; if there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study\r\n* If a patient inadvertently becomes pregnant while on treatment with MK-3475, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patient’s status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within 24 hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed
Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ?18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
Male and female patients must agree to use a highly reliable method of birth control.
Female participants must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or if sexually active, be practicing an effective method of birth control. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation Optional Extension Phase (OEP) Phase:
Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.
If female, must be:\r\n* Postmenopausal for at least 1 year before the screening visit; OR\r\n* Surgically sterile; OR\r\n* Agreeable to practicing 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment
Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
Male and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence; (1) female patients must have a negative pregnancy test at screening; (2) female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for 72 hours prior to admission and to continue its use during the study and for at least 30 days after the final dose; (3) male patients must agree to use an acceptable form of birth control from study day 1 through at least 30 days after the final dose
Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards
Male and female patients who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment
If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
Women of reproductive capability will be enrolled, but each woman needs to discuss with the study team the method of birth control used and if the method is a reliable and effective method for her; if a woman becomes pregnant during the course of active study participation, she must agree prior to enrolling in the study that she will report the pregnancy to the study team; with a confirmed pregnancy, the subject will no longer receive the assigned treatment, but will continue to be followed per protocol
Women of childbearing potential (FCBP) must have a negative urine pregnancy test within 7 days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator
Breast surgeons may recommend that this patient population should not take any oral contraceptives or hormone eluting intrauterine devices (IUDs); sexually active heterosexual women must agree to use an effective form of birth control for the duration of study participation; women who are NOT having 1) a hysterectomy, 2) fallopian tubes removed and/or 3) ovaries removed at the time of their breast surgery will also be required to use an effective form of birth control for 56 days following the last dose of study medication\r\n* The following women are not considered able to bear children and therefore are eligible to participate without the use of concurrent birth control:\r\n** Female with hysterectomy with intact functioning ovaries\r\n** Female with fallopian tubes cut, tied, sealed, or removed\r\n** Female with sterilization implant (e.g. Adiana, Essure) place > 3 months prior to beginning study drug\r\n* One of the following methods of birth control must be used by sexually active women of childbearing potential for the duration of study participation and for 56 days following the last dose of study medication:\r\n** Combined oral contraceptive pill in continuous use for > 90 days prior to study entry\r\n** Vaginal ring (e.g.NuvaRing) in continuous use for > 90 days prior to study entry\r\n** Skin patch (e.g. Ortho Evra) in continuous use for > 90 days prior to study entry\r\n** Injection (e.g. Depo-Proveera, Noristerat) in continuous use prior to study entry\r\n** IUD\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\r\n** Male partner who has had a vasectomy\r\n* Women who indicate that they are abstinent from heterosexual encounters for the duration of study participation and for the 56 days following the last dose of study medication will not be required to use birth control
WOCBP should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded; WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; the male partner of WOCBP subjects enrolled into the trial should be instructed to use a condom by their female partner enrolled in the trial
If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control
If male, must be surgically sterile or willing to practice two effective methods of birth control
Willing to use non-hormonal birth control: Male subjects who are surgically sterile (eg, after vasectomy) or who must agree to use an adequate method of contraception during participation in the trial and for at least 1 complete month after the final dose of trial medication. Female subjects who are surgically sterile (eg, 2-sided tubal ligation, resection or ovariectomy, hysterectomy) or post-menopausal (defined as at least 50 years of age and who have a history of no menses for at least 24 months) or female subjects of childbearing potential with no male partner, or use an adequate method of contraception during participation in the trial and for at least 1 complete month after the final dose of trial medication. An adequate method of contraception is defined as one of the following acceptable birth control methods:
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 6 months after the last drug administration
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study
STRATUM A: Male participants of child fathering potential must be willing to use medically acceptable form of contraception during treatment and for 16 weeks after stopping treatment
STRATUM B: Male participants of child fathering potential must be willing to use medically acceptable form of contraception during treatment and for 16 weeks after stopping treatment
STRATUM C: Male participants of child fathering potential must be willing to use medically acceptable form of contraception during treatment and for 8 months after stopping treatment
Female patients of childbearing potential must have negative serum or urine pregnancy test within 72 hours of the first dose of MEK162; patient must not be pregnant or breast-feeding; patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 30 days following cessation of treatment
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence during study treatment and 12 months after the last dose of alisertib
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Fertile male patients willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops.
Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Subjects of childbearing potential requires acceptable form of birth control
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops
Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat
NON-PROGRESSED DIPG (STRATUM 2): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study (cohort 1)
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study
All patients of childbearing age must use an acceptable form of birth control
All patients of childbearing and child-creating age must be using an acceptable form of birth control
All patients of childbearing and child-creating age must be using an acceptable form of birth control
Pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, and 6 months after the last dose of mFOLFOX6; Men with female partners of child-bearing potential must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of bevacizumab and 6 months after the last dose of mFOLFOX6
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after last administration of ziv-aflibercept; women of child bearing potential must have a negative pregnancy test (urine or blood) within 14 days of registration
Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after completion of atezolizumab administration
Female patients of childbearing age must have negative pregnancy test; 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 30 days after study participation
Women of childbearing potential and men must agree to use adequate contraception with a highly effective method (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation; abstinence is acceptable if this is the established and preferred contraception for the subject
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
Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
The effects of enasidenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment
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 protocol treatment.
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 and for 90 days after completion of ceritinib administration
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 4 months after last dose of temozolomide
Women of child bearing potential must not be pregnant or breastfeeding; a negative urine or blood pregnancy test must be obtained in women with child bearing potential on the day the prior to the first PET scan; men and women with reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) on study entry and for the duration of study participation
Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; subjects should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors
Women of child bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents
Negative pregnancy test (serum or urine) within 14 days of registration in women of child-bearing potential; 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; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib administration
Pregnant women are excluded from this study; women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men should use adequate birth control for at least three months after the last administration of lenvatinib
Women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal, barrier method, or abstinence) prior to study entry, during treatment, and for three months after completing treatment
Women of childbearing potential 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.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence); women must not breast feed while on study
Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of chemoradiation (treatment) and for 3 months after discontinuing treatment; women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to starting treatment
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
Women of child-bearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion
Women of childbearing potential and men must agree to use adequate contraception (simultaneous use of 2 methods of birth control) prior to study entry, for the duration of study participation and for 90 days following completion of therapy.
Women of child-bearing potential and men must be willing to use adequate contraception during the entire study and for 8 weeks following completion of all chemotherapy on study; this includes hormonal or barrier method, or abstinence
Women of reproductive potential 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
Women of reproductive potential 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
Not pregnant; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; pregnancy tests will be obtained per institutional policies
Pregnant women are excluded from this study; women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
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 through 4 months after the end of treatment; for females of childbearing potential, a negative pregnancy test must be documented prior to registration
Pregnant or breastfeeding; a negative serum or pregnancy test is required no more than 7 days before study entry, and patients must be willing to employ adequate contraception; women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
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 4 months after last dose
Subjects of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
Pregnancy or lactation; patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
Eligibility criteria specific to the neratinib arm:\r\n* Participants must be willing and able to provide written informed consent/assent for the neratinib arm of the INSIGhT trial\r\n* Women of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from date of initial dose and for 28 days following the last dose of neratinib; men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during intercourse with women of childbearing potential from date of initial dose and for 3 months following the last dose of neratinib
Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment; female patients of child-bearing potential must indicate to their physician that there is no possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test
If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
Pregnant or breast feeding; for all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required during therapy, prior to study entry, and for the duration of study participation; non-pregnant status will be determined in all women of childbearing potential
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
Women of childbearing potential must use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry until 6 months after the infusion of IMA202 product
Agree to acceptable birth control; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter; men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter
Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 4 months after the last dose of study therapy
Patients who are pregnant, breastfeeding or plan to become pregnant; sexually active patients and their partners must be willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of T-VEC
Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry and for the duration of study participation; women of child-bearing age must have documented negative pregnancy test prior to start of lympho-depleting regimen
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; patients should continue contraceptive measures for 6 months from the last dose of all study medications
Women of reproductive potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry
Women of childbearing potential and men willing to agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to\n             study entry, during the duration of study participation and for at least 4 weeks\n             after withdrawal from the study, unless they are surgically sterilised
Both women and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; if the patient does not agree, the patient is not eligible
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control or abstinence) for the duration of study participation and for 90 days following IPHC
Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Is pregnant or breast-feeding, since the effects of NPC-1C on the developing human fetus and nursing infants are unknown and potentially harmful, women of child-bearing potential must agree to use adequate contraception (hormonal or double barrier method of birth control or complete abstinence) prior to study entry, for the duration of study participation, and for three months after the last dose of investigational agent.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation
Men must agree to use adequate contraception (barrier method or abstinence) prior to study entry and for 30 days after study participation
Women of child-bearing potential and men must agree to adequate contraception (hormonal or barrier method of birth control; abstinence) during and up to 30 days after discontinuing treatment
Males and females of child-bearing potential 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 and for 4 months after the last dose of study chemotherapy
Women of child-bearing potential (WOCBP) 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; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Negative pregnancy testing (by serum beta-human chorionic gonadotropin [hCG]) within 2 weeks of study day 1 during the study intervention for women of child-bearing potential; women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women will not be allowed to be on oral contraceptives or other hormonal birth control methods within 6 months of trial entry and for the duration of the study; if a participant does become pregnant while on study, she will be removed from the study
Women of childbearing potential and men must use two forms of contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 6 months after the final dose of study treatment
Patient agrees to use adequate contraception (barrier method of birth control) prior to study entry, during therapy and up to 3 months after last dose of ipilimumab
Adequate contraception must be used and patients must not be pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men and women should use adequate birth control for at least thirty days after the last administration of sorafenib
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
Pregnant or nursing women are ineligible; 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
Pregnant or nursing women are ineligible; 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
Participating 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
Women of childbearing potential and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to enrollment and for the duration of study participation; protections against pregnancy must be continued for at least 8 months after the last dose of study drug
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
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) beginning 14 days prior to first dose of pazopanib, through the dosing period, and for at least 28 days after the last dose of pazopanib
Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation; non-pregnant status will be determined in all women of childbearing potential
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
Women of child-bearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 3 months after completion
The effects of dendritic cell vaccines on the developing human fetus are unknown; for this reason men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least three months following the last dose of experimental therapy and must have a negative urine or serum pregnancy test within 7 days prior to the start of the study
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, throughout the duration of study participation and for 6 months after the final scheduled study visit
Non-pregnant and non-nursing women\r\n* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment\r\n* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of AZD1775 and belinostat administration
Must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
15. Men and women of childbearing potential must agree to use adequate contraception(double barrier birth control) for the duration of study therapy and for 3 months after the last dose of VS-6063.
Women of childbearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to beginning ADAPT therapy and for the duration of study participation
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence); women must not breast feed while on study
Men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment
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. 10. Ability to understand and the willingness to sign a written informed consent document.
Women of child-bearing potential (WOCP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
Pregnancy and breast feeding are exclusion factors; enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 3 months after the end of the treatment
Women of childbearing potential with a positive serum pregnancy test performed within 7 days prior to the start of treatment; women and men of childbearing potential that do not agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men who do not agree to use adequate birth control for at least three months after the last administration of sorafenib
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation
Men must agree to use adequate contraception (barrier method or abstinence) prior to study entry and for 30 days after study participation
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following SBRT
There is no available information, as yet, regarding human fetal or teratogenic toxicities; pregnancy tests with a negative result must be obtained in girls who are postmenarchal within 10 days before start of treatment; women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men and women should use adequate birth control for at least three months after the last administration of study treatment
Because the teratogenicity of cixutumumab is not known, women of childbearing potential (WOCBP) 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
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
Men and women of childbearing potential must agree to use adequate contraception (double barrier birth control) for the duration of study therapy
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
Participants of child-bearing or child-fathering potential must agree to use adequate contraception (hormonal birth control; intrauterine device; double barrier method; or total abstinence) throughout their participation, including up until 30 days after last dose of CUDC-907
Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment
Pregnant women are excluded from this study; women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
Female subjects of child-bearing potential must agree to use an adequate form of contraceptive (e.g., hormonal, barrier method or abstinence) prior to study entry and for the duration of the trial.
Fertile subjects must use adequate contraception (abstinence, barrier methods, or birth control pills) prior to study entry and for the duration of study participation
Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
TREATMENT GROUP: Not pregnant and willing to use adequate contraception (barrier method of birth control or abstinence) for the duration of study participation
NORMAL GROUP: Not pregnant and willing to use adequate contraception (barrier method of birth control or abstinence) for the duration of study participation
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
Negative pregnancy test; women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent.
Negative serum pregnancy test within 72 hours before starting study treatment for women of childbearing potential. Women of childbearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of monalizumab administration and for up to 5 months after the last dose of monalizumab.
Woman of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (i.e., no menstrual bleeding for more than 12 months in a women aged 45 years or more), OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least 2 acceptable methods of birth control, one of which must be highly effective, during the study and for at least 180 days after stopping TRC105 or pazopanib
Woman of non-child bearing potential due to surgical sterilization confirmed by medical history or menopause, OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least 2 forms of a reliable and highly effective method of birth control during the study and for at least 180 days after stopping TRC105 or sorafenib.
Females who are pregnant or lactating, fertile males, or females of child-bearing potential who are not willing to comply with an effective double method of birth control are NOT eligible for participation
Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug; both males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; female patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses
Female subjects (if of child bearing potential) and male subjects (with a partner of child bearing potential) must use medically acceptable methods of birth control before study entry, for the duration of the study, and for at least 6 months after the last intake of study drug.
Females of child-bearing potential and sexually-active males must consent to follow acceptable birth control methods to avoid contraception while on treatment
Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen; females of child-bearing potential must have a negative pregnancy test
Sexually active females of childbearing potential and males with partners of child bearing potential must agree to use birth control
Women of child bearing potential (WOCBP) must be willing to use medically acceptable methods of birth control during the study treatment and for one month after discontinuing study treatment
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
Women of child-bearing age and all men must use birth control of any type until at least 12 months after the last dose of therapy
TREATMENT WITH SJCAR19: For females of child bearing age:\r\n* Not lactating with intent to breastfeed\r\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\r\n* If sexually active, agreement to use birth control until 6 months after T-cell infusion; male partners should use a condom
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
Subjects of child bearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen; females of child bearing potential must have a negative pregnancy test
Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
Willing to use appropriate birth control for patients of child-bearing potential;
Have a negative serum beta human chorionic gonadotropin (?-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly prior to study entry, for the duration of study participation and for at least 4 weeks after treatment has ended
Women of child-bearing potential (WOCBP) must be willing to use acceptable means of birth control
For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control throughout the trial starting with the screening visit through 120 days after the last dose of study medication\r\n* Abstinence is an acceptable method of birth control
Male subjects with a female partner(s) of child-bearing potential must agree to use acceptable birth control throughout the trial starting with the screening visit through 120 days after the last dose of study medication
Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period; women of child bearing potential must have a negative urine pregnancy test at the time of enrollment; acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment
No pregnant or breastfeeding women; men or women of child bearing potential must agree to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for at least 90 days after last study treatment (radiation or fresolimumab); all women of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy at pre-entry
WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Woman of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause, OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least 2 forms of a reliable and highly effective method of birth control during the study and for at least 180 days after stopping TRC105, bevacizumab, paclitaxel, and/or carboplatin
Men and women of child-bearing potential must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy
Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment; females must agree to adequate birth control if conception is possible during the study
Female subjects of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for 30 days after stopping study medication.
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Women of child bearing potential must agree to use birth control for the duration of the study
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child (a) while receiving treatment of guadecitabine, decitabine, or azacitidine and for at least 3 months after completing treatment and (b) while receiving treatment with high-intensity TC or LDAC and for at least 6 months after completing treatment.
Not pregnant, and on appropriate birth control if of child-bearing potential
Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control
Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
The subject must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
Pregnant women are excluded from this study; breastfeeding should be discontinued; women of child-bearing potential must agree to use adequate birth control throughout the study duration
If of child-bearing potential, patient agrees to use adequate birth control measures during study participation
If the subject is female and of child-bearing potential, subject must have negative serum or urine pregnancy test within 7 days of treatment with research agent; men with partners of child-bearing potential and women of child-bearing potential must be willing to use medically effective birth control methods, e.g. contraceptive pill, condom, or diaphragm and continue this for one year post HSPC infusion
If the subject is female and of child bearing potential, subject must have negative serum or urine pregnancy test within 7 days of treatment with research agent; men with partners of child-bearing potential and women of child-bearing potential must be willing to use medically effective birth control methods, e.g. contraceptive pill, condom, or diaphragm and continue this for one year post HSPC infusion
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration; postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential; men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
Females of child-bearing potential and males who use adequate birth control through 120 days post dose.
Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]; see protocol for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in the protocol) and must agree not to become pregnant or father a child while receiving treatment with study drug and for at least 3 months after completing treatment. Contraceptive measures which may be considered highly effective comprise combined hormonal contraception (oral, vaginal, or transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence, and surgically successful vasectomy. Abstinence is acceptable only if it is consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of birth control.
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study
Non-child bearing potential or able to follow birth control requirements
Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 30 days following the last study treatment.
Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy
Pregnant women are excluded; we recommend that women of child-bearing potential use an acceptable method of birth control to avoid pregnancy for 6 months following stereotactic radiosurgery and that male subjects use effective contraception for the same period
Women of child bearing potential must have a negative pregnancy test within 14 days prior to study registration and agree to use adequate birth control during study treatment
Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of study drug
Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control; women of childbearing potential must undergo a pregnancy test within seven days of starting the study drug
Pregnant women and women of child-bearing potential who are not using an effective method of birth control
Females of child-bearing potential and sexually-active males must consent to follow acceptable birth control methods to avoid contraception while on treatment
Sexually active subjects must agree to use medically accepted methods of birth control during the course of the study and for 3 months following discontinuation of study treatments (excluding women who are not of child bearing potential and men who have been sterilized)
Men and women of child-bearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished
Women of child bearing potential must have a negative pregnancy test within 28 days prior to study registration and agree to use adequate birth control during study treatment
Pregnant or breast feeding women, or women of child-bearing potential (and/or their partners) who are unwilling to utilize an approved method of birth control during the study and for 1 month afterward
Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued; all males of child fathering potential must also be willing to practice effective birth control
For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab.
Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 60 days following the last study treatment.
Women must be either of non-child bearing potential, or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study
Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
Women of child-bearing potential must be willing to practice acceptable methods of birth control. Additionally, women of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study medication.
Pregnant or lactating females are excluded. Women of childbearing age, and their sexual partners, must use an effective contraception program. Males who are having sexual relations with women capable of child bearing must use the barrier birth control while on the study and for 3- months after the last dose of the study drug.
Females of child bearing potential (defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy, or are not naturally postmenopausal ? 24 consecutive months) must have negative urine or blood pregnancy test prior to enrollment and use adequate birth control methods (abstinence, oral contraceptives, barrier method with spermicide, or surgical sterilization) during study participation. Males must agree to use a latex condom during any sexual contact with females of child bearing potential while participating in the study and for 12 weeks following the last dose of dalantercept, even if he has undergone a successful vasectomy. Patients must be counseled concerning measures to be used to prevent pregnancy and potential toxicities prior to the first dose of dalantercept.
Women with child-bearing potential must be willing to practice acceptable methods of birth control during the study
Women must be either of non-childbearing potential or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
Females of child-bearing potential must be willing to practice acceptable methods of birth control. Additionally, females of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of study drugs, throughout treatment period and for 4 months after last dose of study drugs.
Females of child-bearing potential (with negative serum pregnancy test within 7 days prior to the first dose of study medication) must be willing to practice acceptable methods of birth control .
of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to use protocol specified methods of birth control while on study.
Patients of reproductive potential (female of child bearing potential has not been postmenopausal for at least 12 consecutive months or not surgically sterile; male of child bearing potential has not been surgically sterile) must follow accepted birth control methods (e.g. barrier method) during treatment
Pregnant or lactating females are excluded. Women of childbearing age, and their sexual partners, must use an effective contraception program. Males who are having sexual relations with women capable of child bearing must use birth control while on the study and for 3-months after the last dose of the study drug.
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
Male and female subjects of child-bearing potential must agree to use medically acceptable methods of birth control throughout the study and for thirty (30) days after the last dose of study medication.
Women of child bearing potential must have a documented negative pregnancy test within 2 weeks prior to day 1 of treatment and agree to use a non-hormonal form of birth control during the duration of the trial therapy
Agree to utilize medically accepted methods of birth control during study participation and for 90 days following the last treatment with study drug if a female subject is of childbearing potential or if a male subject has an opposite sex partner of child bearing potential.
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
Females (of child bearing potential) and males (of child bearing potential) must be abstinent or agree to use birth control during the study
Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
Women of child-bearing potential must be willing to practice an effective method of birth control while on study
Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished
Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD
Women of childbearing potential are willing to agree to use 1 of the study-defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 1 week (women) or 12 weeks (men)
Women of childbearing potential are willing to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel; all men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment
Inability or refusal to practice effective contraception during therapy; men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of the treatment
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
Women of childbearing potential must use an acceptable form of birth control for 28 days prior to beginning study treatment, through the duration of study treatment, and for 3 months after discontinuing study treatment
Subjects of reproductive potential who are not willing to employ effective birth control from screening to 1 year after last dose of vaccine
Subjects of reproductive potential who do not use effective methods of birth control
Men and women of childbearing potential must practice birth control; women of child bearing potential must have a urine pregnancy test within 7 days of study entry; in accordance with topotecan hydrochloride (topotecan) administration guidelines, women must practice birth control for at least 1 month following chemotherapy infusion; men must practice birth control for at least four months following termination of chemotherapy infusion
Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
All sexually active subjects of reproductive potential are required to use or start using a reliable method of birth control at least 2 weeks prior to study enrollment, throughout the study, and for at least 3 months following completion of study therapy.
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment.
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Subjects of reproductive potential must agree to use acceptable birth control methods
Women and men of reproductive potential who are unwilling or unable to use an effective means of birth control during the study and for 3 months after receiving study drug
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study if randomized to SBRT treatment arm)
Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and for at least 4 months following treatment on study
Women of childbearing potential and men must agree to use a medically accepted form of birth control during the treatment and for 2 months following completion of study treatment
Pregnant and nursing women should be excluded from the protocol; if the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy; it is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study
Women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation and for 2 months following completion of study treatment
Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
Women who are pregnant (confirmed by a serum pregnancy test in females of reproductive potential) or breast-feeding; women of child-bearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment (unless the subject or subject’s partner(s) is sterile (i.e. women who have had a hysterectomy or have been post-menopausal for at least twelve consecutive months) or remain abstinent, men and women of reproductive potential must agree to use TWO of the following forms of birth control every time they have sex throughout the study and for up to 3 months following discontinuation of study drug: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicidal, intrauterine device (IUD), or surgical sterilization while participating in this study; hormonal birth control methods are not permitted
Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/ custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 5 weeks (women) or 3 months (men) after receiving the last dose of AMG 232; acceptable methods of effective birth control include sexual abstinence (men, women); vasectomy; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or IUD (women)
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
Pregnant and/or lactating women will be excluded; premenopausal patients will undergo pregnancy testing when indicated; women will practice effective birth control while receiving protocol treatment
Any women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control
Non pregnant and non-nursing; treatment under this protocol would expose a fetus to significant risks; women of childbearing potential should have a negative pregnancy test prior to study entry; women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
Women of childbearing potential and fertile men who are not practicing or who are\n             unwilling to practice birth control while enrolled in the study until at least 12\n             weeks after the last milatuzumab infusion
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
Pregnant and lactating women are excluded from this study; women of reproductive potential that are not using or are unwilling to use effective birth control methods throughout the trial are excluded
Men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Men and women with reproductive potential: Must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer.
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment
Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 5 weeks (women) or 3 months (men) after receiving the last dose of AMG 232; acceptable methods of effective birth control include sexual abstinence (men, women); vasectomy; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or intrauterine device (IUD) (women)
Women of childbearing potential must agree to use highly effective methods of birth control.
Women and men of reproductive potential should agree to use two effective means of birth control\r\n* For women, contraception should continue for 23 weeks after the last dose of nivolumab and 12 weeks after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body\r\n* For men, contraception should continue for 31 weeks after nivolumab and 12 weeks after dasatinib
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization; postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential, women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug, All WOCBP MUST have a negative pregnancy test prior to beginning ibrutinib on study
Male and female patients of reproductive potential must agree follow accepted birth control measures
Note: Women with potential to have children must be willing to practice acceptable methods of birth control during the study
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of treatment)
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with 5-azacitidine; all men and women of childbearing potential must use acceptable methods of birth control throughout the study
Non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control
Females who are pregnant or breast-feeding during the study period will be excluded; adults of reproductive potential not employing an effective method of birth control will be excluded; sexually active women of child bearing potential, whose partner is male, must use medically accepted birth control; sexually active men, whose partner is a female of childbearing potential, must use a medically accepted birth control
Subjects of reproductive potential agree to use birth control throughout their participation in this study, and for three months following study termination.
Men and women with reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment
Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control
Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study
Patients must not be pregnant; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
Women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation and for 4 months following completion of study treatment
Pregnant and lactating women will be excluded; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study
All subjects of childbearing potential must agree to use acceptable methods of birth control (men and women)
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Women of childbearing potential and male participants must agree to practice adequate means of birth control throughout their participation in the study and for 6 months after their last treatment
Not pregnant or breast feeding; women of childbearing potential and sexually active men must agree to use an accepted and effective method of birth control
Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.
Pregnant and/or lactating women will be excluded; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for four months after completion of treatment)
Women with potential to have children must be willing to practice acceptable methods of birth control during the study;
Women and men agree to use protocol specific birth control measures
If female patient with reproductive capacity: on effective means of barrier birth control during the entire duration of the treatment
Pregnant women are ineligible, as treatment involves unforeseeable risks to the embryo or fetus; female patients with reproductive capacity are required to use effective means of birth control during the entire duration of the treatment
Women and men of reproductive potential must agree to use an effective means of birth control during the study and for 3 months after receiving study drug
Pregnant or breast feeding; women and men of reproductive potential must agree to use an effective means of birth control during the study and for 3 months after receiving study drug
For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
Women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug
Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control
Subjects who are of reproductive potential who refuse to use effective methods of birth control during the course of participation of the study and within 5 month for women and 7 months for men of the last dose of investigational agent are ineligible to participate in the study.
Patients must not be pregnant; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
Female participants of childbearing potential must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study; WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
Negative pregnancy test at the Screening visit for women of childbearing potential and willingness to use adequate birth control
Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Male patients with female partners of childbearing potential, and female patients of childbearing potential must agree to use effective birth control. Effective birth control and cessation of lactation must be complied at least 2 weeks prior to first study drug administration, during the trial participation, and for 3 months after the last dose of study drug
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of childbearing potential must agree to use adequate contraceptive measures until 3 months after the last study drug is taken. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. Women of childbearing potential must have a negative pregnancy test. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
Pregnancy or lactation. Pregnancy is associated with considerable immune suppression and this additional parameter may interfere with the evaluation of dendritic cell induced immune responses in melanoma study subjects. Pregnancy test must be negative on all women of reproductive potential at baseline (within 7 days of entry into the study) and they must agree to use birth control measures while on the study
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within 21 days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to 30 days after the completion of adjuvant therapy
Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day 1 through at least 90 days after the last dose of study drug.
Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; Note: patients must agree to adequate birth control during the study and for up to 6 months after discontinuation of study medication
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
Patients of childbearing potential must agree to use adequate birth control during and for 3 months after participation in this study
A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study
Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of ODM-201.
Male and female patients of reproductive potential must agree to follow accepted birth control measures throughout the study period and for 30 days after the last dose of either study drug for females and 3 months after the last dose of study drug for males
Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug.
Pre-menopausal patients must have a negative pregnancy test and agree to use birth control methods while participating in the study; women of childbearing age and their male counterparts should use a barrier method of contraception during and for 3 months following protocol therapy
Women of child-bearing potential must have a negative pregnancy test within 10 days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for 3 months after radiation; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year
Patients of childbearing potential must agree to use an effective birth control method
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment; patients must agree to use a reliable barrier method of birth control during and for 3 months following the last dose of study drug
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
Agree to use adequate birth control, if of childbearing potential
Females of childbearing potential must have a negative pregnancy test result before enrollment. Males and females of childbearing potential must agree to use a highly effective method of birth control during the study for at least 30 days after enrollment in the study.
Female participants / women of childbearing potential (WOCBP) must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study. WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment.
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication
Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving treatment with guadecitabine, LDAC, or IC and for at least 3 months after completing treatment.
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for 3 months after receiving their last dose of study drug; fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to 6 months after discontinuation of study drug treatment
Patients (men and women) of childbearing potential must agree to use double barrier method of birth control beginning at the signing of the informed consent form (ICF) until at least 3 months after the last dose of study drug
Female and male subjects must agree to use a medically acceptable method of birth control prior to screening and agree to continue its use throughout the study; females of childbearing potential should be counseled in the appropriate use of birth control while on this study
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Patients of childbearing potential must agree to use an approved method of birth control
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product; a positive pregnancy test will prohibit the subject from receiving the investigational product
Patients of childbearing potential must have a negative blood pregnancy test within 14 days of treatment; patients must agree to use a reliable barrier method of birth control during and for 3 months following the last dose of study drug
Women of childl-bearing potential must have a negative pregnancy test within 7 days prior to starting the study drug. Beth males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose
Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 3 months following the last dose of the study drug, in a manner such that risk of pregnancy is minimized; surgical sterilization, intrauterine device, birth control pills, or barrier method (e.g. condom and/or diaphragm with spermicidal agents) are acceptable forms of birth control; women of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to treatment; a pregnancy test is not required for registration; women who have not menstruated for more than 2 years will be considered postmenopausal, thus not of childbearing potential
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >=1 year; men who are able to father a child must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose
Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Males must have undergone sterilization- vasectomy, or utilize a barrier method
Patient of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing and effective form of birth control
Or, if of childbearing potential: must have a negative urine pregnancy test at Screening and on Day 1 before the first dose of study drug is administered, and must use 2 acceptable methods of birth control* if sexually active from Screening through 3 months after the last dose of study drug.
Willingness to use acceptable birth control. Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female subjects of child-bearing potential must have a negative pregnancy test.
Women of childbearing potential (less than 12 consecutive months since last regular menses, or surgically sterile) must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test and must agree to use hormonal, intrauterine device (IUD), or barrier birth control with spermicide to avoid pregnancy during the study; agreement to participate in this study via the informed consent will indicate subjects commitment to subject avoid pregnancy in self or a partner of childbearing potential for up to 6 months after the last dose of study therapy
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment; patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year; men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus
Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
Women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study
Women of childbearing potential (WOCP) must have a negative pregnancy test result prior to enrollment. WOCP and men whose partners are WOCP must agree to use a highly effective method of birth control during the study and for 6 months following the last dose of study drug. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; surgical sterilization is considered non-childbearing potential; female patients of reproductive potential must agree to employ an effective method of birth control (hormonal or barrier) throughout the study and for up to 3 months following discontinuation of study drug
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 3 months after the last dose of study drug, Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
Subjects who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female subjects need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if subject is of childbearing potential. Non?childbearing is defined as ? 1 year postmenopausal or surgically sterilized).
Female subjects of childbearing potential must have negative pregnancy test within 7 days prior to first dose of study drug; practicing an acceptable form of birth control for greater than 2 months prior to screening and commits to use for the duration of the study and for 3 months following the last dose of study treatment.
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
Women able to conceive and unwilling to practice an effective method of birth control from screening until 90 days after discontinuing study treatment (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose of PQR309).
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug. Fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose.
If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use two acceptable methods of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they meet at least one of the following criteria:
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
Females or males whose partners are women of childbearing potential must agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation
Women of childbearing potential are will to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 60 days after the final study drug administration
Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after the last dose of study drug.
Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);
Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta (b)-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth control specifications: women who are able to become pregnant must use birth control during the study and for 30 days after
Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications; women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
Females of childbearing potential must use a highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept
Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
Female patients of childbearing potential must agree to use an acceptable method of birth control from the signing of informed consent form and to continue its use during the study and for at least 90 days after the final dose
Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
Male and female subjects of childbearing potential must agree to use a highly reliable method of birth control (expected failure rate < 1% per year) from the Screening Visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
Female participants: Are women of child-bearing potential who test negative for pregnancy within 7 days prior to enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study and for 12 weeks following the last dose of the study drug and also must not be breastfeeding, OR are postmenopausal women.
Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration
Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for >= 12 months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for 13 weeks after last study drug administration. Please note that the efficacy of hormonal contraception may be decreased if administered with olaparib.
Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator (PI) during the treatment period and for 1 week after last dose of AA
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for 1 week after last dose of abiraterone acetate
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for 1 week after last dose of enzalutamide
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of abiraterone acetate
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of ranolazine
Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:\r\n* Women whose sexual orientation precludes intercourse with a male partner\r\n* Women whose partners have been sterilized by vasectomy or other means\r\n* Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable)
Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control
Men and women of childbearing potential should practice 2 methods of contraception; 1 method must be highly effective and a second method must be either highly effective or less effective; men and women of childbearing potential are defined as: a male that has not been surgically sterilized or a female that has not been amenorrheic for at least 12 consecutive months or that has not been surgically sterilized; patients must use birth control during the study and for 3 months after the last dose of study drug if they are sexually active
Contraception in patients with preserved reproductive capacity; patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal for at least two years; women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least three months (in case of monotherapy with BIBF 1120) after the end of active therapy are not allowed to participate in the trial; a highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner
Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to registration; exceptions: females not of child-bearing potential due to surgical sterilization (at least 6 weeks following tubal ligation, hysterectomy, or surgical bilateral oophorectomy with or without hysterectomy) confirmed by medical history; or female after menopause\r\n* A “postmenopausal woman” is a woman meeting either of the following criteria:\r\n** Spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example, oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators [SERMs], or chemotherapy)\r\n** Spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level > 40 mIU/mL \r\n* Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 12 months following the last dose of study treatment; a highly effective method of birth control is defined as one that results in a low failure rate (that is, < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females) during the trial and for at least three months after end of active therapy (contraception in patients with preserved reproductive capacity, patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years)
Sexually active women of childbearing potential must commit to 2 methods of contraception while enrolled on the trial and continue using contraceptives for at least 7 months post study drug administration; sexually active men must commit to 1 method of contraception while enrolled and for 7 months after; hormonal contraceptives such as birth control pills, patches, implants or injections are not allowed in patients who are hormone receptor (HR) positive (+)
The following patients will be excluded from this study:\r\n* Pregnant women\r\n* Breastfeeding women\r\n* Men or women who are sexually active and unwilling to use a medically acceptable method of contraception (e.g., such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 6 months after end of active therapy; a highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least 2 years
Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.
Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy
Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment\r\n* Patients will be considered to be of childbearing potential unless surgical sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years; women of childbearing potential who are sexually active and not using a highly effective method of birth control before the trial for at least one month, during the trial, and for at least three months after the end of active therapy are not allowed to participate in the trial; a highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomized partner
Pregnancy or lactation or unwillingness to use adequate method of birth control.
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal renal function, mild, moderate, or severe renal impairment and is not on\n             dialysis\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, within the specified time\n             frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
If fertile, willing to use effective birth control methods during the study
Highly effective forms of birth control include:
Highly effective forms of birth control include:
Patient on reliable birth control: combined oral contraceptive pill (OCP), long acting reversible contraceptive program (LARCP), bilateral tubal ligation (BLT) and Depo Provera shot/birth control shot
Patient not on reliable birth control
Willingness to use 2 methods of birth control during the study and for 12 months after the last dose of ZW25
Patients of reproductive potential must use an acceptable form of birth control or abstain from sexual activity
Female of childbearing potential, unless birth control used on study and 12 wks post-treatment.
Male patients must agree to use adequate birth control during the study and up to 30 days after the last avelumab dose
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
Not willing to use an effective method of birth control
Inability to comply with study procedures or willingness to use adequate birth control
Willing to follow strict birth control measures
Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device (refer to Section 7.3 Permissible and Prohibited Medications/Treatments)
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.
Men who could potentially father a child must also use birth control
All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
Using corticosteroids or estrogen-based oral birth control
Women of childbearing potential (WOCBP) who are pregnant or lactating or unwilling to use 2 forms of effective birth control
Effective birth control should be utilized as indicated
Males must agree to use a medically acceptable form of birth control in order to be in this study and for 3 months after infusion
Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation
Women who are able to become pregnant and men who can father a child must use birth control while on study and for at least 8 weeks after your last dose of study drug(s); acceptable birth control includes a condom or a diaphragm with spermicidal jelly; and birth control methods that are taken by mouth, injected, or implanted; if you are already using birth control, you must check with the study staff to make sure that it is considered one of the acceptable forms to use in this study
Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent\r\n* Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence [no sexual intercourse] or surgical sterilization)
Be non-fertile or not pregnant or lactating & agree to use birth control during the study through the end of last treatment visit
No patients who are pregnant or lactating will be allowed; patients of childbearing potential must practice an effective method of birth control while participating on this study
Patients who do not agree to practice appropriate birth control methods while on therapy.
Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
Females must not be pregnant or breast feeding, and must use accepted birth control methods; males must use accepted birth control methods
Females of childbearing age must be on an acceptable form of birth control per institutional standards
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Subjects are required to agree to practice effective birth control (i.e. abstinence, intrauterine device for female subjects) during the study period.
218 Males and females of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study through 110 days (females) and 170 days (males) after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (males) in combination with hormonal birth control or intrauterine device (IUD) (females).
All patients must practice a highly effective method of birth control
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Male patients must agree to use adequate birth control during the study and up to 6 months after discontinuation of study drug treatment
Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination
Adequate birth control
Adequate birth control in sexually active women of childbearing potential
Pregnancy or nursing or unwilling to take adequate birth control during therapy; NOTE: breastfeeding should be discontinued
Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 6 months after the last vaccination therapy
Patients must not be pregnant, lactating, or unwilling to use birth control
Females of childbearing potential and males not using adequate birth control.
Patients must be able to rinse and expectorate study medication rather than swallow it; female patients must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP
Pregnancy or nursing or unwilling to take adequate birth control during therapy
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
Agree to use a reliable medically approved method of birth control.
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Patients with childbearing potential must agree to use appropriate forms of birth control
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 90 days after the last dose of study treatment; acceptable methods of birth control include condoms with birth control foam, birth control pills, implantable or injectable birth control, birth control patch, intrauterine device (IUD), or diaphragm with spermicidal gel; male patients must use an effective barrier method of contraception (i.e. , condoms with birth control foam or diaphragm with spermicidal gel) during the study and for 90 days following the last dose of study treatment if sexually active with a female of childbearing potential; contraception must be in place at least 2 weeks prior to initiating study treatment; a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Willing to employ adequate and appropriate birth control if applicable\r\n* NOTE: This study is for patients aged 60 and older and most female patients will have entered menopause by this time; however patients should not become pregnant while on this study; pre-menopausal women need to use birth control while on this study and women should not breastfeed a baby while on this study; any man treated on this study will also need to use contraception if his partner is a premenopausal female; patients should check with their health care provider about what kind of birth control methods to use and how long to use them
Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
Two acceptable forms of birth control include:
Willingness to use birth control while on study
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
Patients of both gender must practice a barrier method of birth control while participating in this trial
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control for the duration of the study.
Woman of potential childbearing age agrees to a medically effective birth control method,
Highly effective forms of birth control include:
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control
The patient is pregnant or unwilling to practice appropriate birth control
Adequate birth control in fertile patients
Adequate birth control when appropriate
Any risk of pregnancy - ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or menopause
Not pregnant, not lactating, and agree to use effective birth control
FCBP must agree to use a highly-effective form of birth control while taking the study drug and for 1 month after the last dose of study drug; highly-effective forms of birth control include implants, injectables, birth control pills with 2 hormones, some intrauterine devices (IUDs), or having a sterilized partner; the type of birth control used must be discussed with and approved by the attending physician prior to initiation of study drug
Willing to use physician approved birth control method
Patients who are known or thought to be sexually active must use effective birth control.**
Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.
if heterosexually active must use two forms of birth control
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal hepatic function, mild, moderate, or severe hepatic impairment\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, shunt in the liver within\n             the specified time frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
Adequate birth control methods for the duration of the study
Unwillingness to practice birth control
Highly effective methods of birth control for females & males
Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables ( i.e. depo-provera)
Adequate birth control
Use of acceptable birth control
Female patients of childbearing age not on effective birth control
Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.
Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, intrauterine device [IUD]) or currently pregnant
Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period
Patients must agree to use an effective birth control method
For sexually active females, patient agrees to use acceptable method of birth control
Acceptable birth control.
Participant must be willing to use two effective forms of birth control during protocol therapy; men and women must continue using two effective forms of birth control for 6 months following treatment
Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
If currently menstruating, subjects must use a reliable method of birth control
Pregnant, or had given birth, or nursed at any time during the last 12 months
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
Male patients must agree to use an acceptable form of birth control from study day 1 through at least 90 days after the final dose
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
Must agree to use effective consistent contraception. Hormone-based birth control (pills, patches, or shots) is allowed. Hormone replacement therapy is not allowed for postmenopausal participants.
CONTROL GROUP
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study.
Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
Not currently on estrogen medication for birth control, menopause, or other reason
Willingness to use birth control while on study
CONTROL GROUP
Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
Women of childbearing potential not practicing adequate forms of birth control
Adequate birth control
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.