Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
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
Females of child-bearing potential cannot be pregnant or breast-feeding; female participants > 10 years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment
Pregnancy. If a woman has been confirmed as pregnant she will not be eligible to take part in the trial. If she suspects there is a chance that she may be pregnant, a pregnancy test should be undertaken; however, a pregnancy test for all women of child-bearing potential is not mandatory
Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration
For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
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.
A negative serum pregnancy test is required for female participants of child bearing potential (?13 years of age or after onset of menses)
Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment
Negative serum pregnancy test in women of child-bearing potential within 7 days of day 1 (D1) of treatment
Men with child bearing potential are required to use an effective means of contraception
A negative serum pregnancy test is required for female participants of child bearing potential (?13 years of age or after onset of menses)
Females should be using adequate contraceptive measures, not be breast feeding and must have negative pregnancy test prior to start of dosing if of child-bearing potential
Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test; both male and female patients of 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
Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
Negative pregnancy test for women of child bearing potential
Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
Of non-child-bearing potential (surgically sterilized or at least 2 years postmenopausal); or
Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential
Negative pregnancy test in women of child bearing potential
Pregnant or breast-feeding women will not be entered on this study; women of childbearing potential must obtain a pregnancy test; child-bearing potential is defined as having neither of the following:\r\n* >= 12 months of non-therapy-induced amenorrhea)\r\n* Surgically sterile (absence of ovaries and/or uterus)
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year.
Women of child bearing potential and men must agree to use contraception prior to study entry and through day 100 post HCT.
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Women of child bearing potential who are pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing.
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
Females of child-bearing potential (FOCBP) must have a negative pregnancy test within 28 days prior to registration on study
Female subjects with child bearing potential must have a negative pregnancy test at screening; child bearing potential is defined as sexually active patients with menses less than 1 year prior to enrollment, < 65 years of age, have no history of oophorectomy or hysterectomy
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
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.
Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of child bearing potential only
Negative pregnancy test in women of child-bearing potential
Women of child-bearing potential (WOCBP) not practicing an effective method(s) of contraception.
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
Female patients of child bearing potential must have negative serum pregnancy test at screening
Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of child-bearing potential
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 who are pregnant or breastfeeding; females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
Female subjects of child-bearing potential must have a negative serum pregnancy test within 14 days of the first day of drug dosing.
Negative pregnancy test for women of child bearing potential
Pregnant women are excluded from this study; breastfeeding women are also excluded; female subjects of child bearing potential must have a negative serum pregnancy test obtained prior to trial registration
Female patients of child-bearing potential and male patients with sexual partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period. Examples of acceptable contraception methods include:
Female patients of child bearing potential must not be breastfeeding or pregnant as evidenced by a negative pregnancy test
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding at the time of screening, during the study and until 3 months after completion of study, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling 1 of the following criteria at screening:
Patients must not be pregnant or nursing; women/men of reproductive potential must agree to use an effective contraceptive method during and for 6 months after completing protocol treatment; a negative pregnancy test is required within 7 days prior to registration for women of child-bearing potential
Female patients of child bearing potential must have a negative pregnancy test within 7 days from the time of registration
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
If of child-bearing pIf of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of study medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of study medication.
Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing
If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
A negative urine or serum pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
Women of child-bearing potential
Women of child-bearing age must obtain a pregnancy test and pregnant or breast-feeding females are excluded
Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant
Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period and for 4 months after the last dose of study drug, who are not breastfeeding, and who have had a negative serum/urine pregnancy test ?7 days prior to dosing
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; female patients of child-bearing potential must have negative pregnancy test
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential who are pregnant or breastfeeding
AUTOLOGOUS APHERESIS: 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
Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
Women of child-bearing potential must have a negative pregnancy test
Negative serum or urine pregnancy test for women with child-bearing potential
Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential
Female patients who are not of child-bearing potential and female patients of child-bearing potential who have a negative serum pregnancy test within 3 days prior to cycle 1, day 1
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
Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing
Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 28 days before study enrollment
Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
Females of child bearing potential must have a negative serum pregnancy test with 7 days prior to first dose of treatment and use 2 methods of contraceptives while on treatment
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Females should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
Women of child-bearing potential, who are biologically able to conceive, and not employing two forms of highly effective contraception; highly effective contraception must be used throughout the trial and up to 8 weeks after the last dose of study drug (e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device); women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ? 14 days prior to starting study drug
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures.
Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for 30 days after the last dose of GC4419. This includes any woman who has experienced menarche but has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential.
Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception
Subjects who are pregnant or planning to become pregnant during the study; women of child bearing potential must have a negative pregnancy test
A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days from the time of registration
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (?7 days prior to 1st study drug dose) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year.
If female and of child-bearing potential, must:
Men and women of child-bearing age need to commit to using two methods of contraception simultaneously to avoid pregnancy.
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 who are pregnant or breastfeeding; females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
For females of child-bearing age, a negative pregnancy test.
Women who are pregnant or lactating; patients must be either surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using acceptable methods of contraception if they are of child bearing potential; female patients of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to starting drug; breastfeeding should be discontinued if the mother is treated with radiation
Women of child-bearing potential must have a negative pregnancy test within 1 week of IORT treatment
Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative of the negative pregnancy test through the radiation treatment period
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: For women of child-bearing potential, a negative serum pregnancy testing will be verified within 7 days prior to treatment
Pregnant or lactating women; women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 3 days prior to start of study drug
Negative serum pregnancy test for women of child bearing potential; NOTE: a female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the patient surgically sterile, or > 2 years since last menstruation
Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 150 days after the last dose of study therapy (for women of child-bearing potential) or 210 days after the last dose of study therapy (for men who have partners of child-bearing potential)
If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
Women of child-bearing potential must have a negative pregnancy test; women of child-bearing potential are defined as all women who are not post-menopausal or who have not had a hysterectomy; postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential without a serum negative pregnancy test and not willing to refrain from sexual activity or to utilize an adeguate contraceptive methods during all the course of the study
Negative pregnancy test for women of child bearing potential
Women of child-bearing potential has negative pregnancy test within 72 hours of initiating study drug dosing
Women of child-bearing potential must have a negative pregnancy test 7 or fewer days from registration
Negative pregnancy test in women of child-bearing potential
Women of child bearing potential who are pregnant or breastfeeding
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
Positive beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as \all female patients unless they are post-menopausal for at least 3 years or surgically sterile\;
Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception;
(For both cohorts A and B): Women of child-hearing potential (WCBP) must have a negative pregnancy test within 3 days prior to the first dose of study treatment
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.
Negative serum pregnancy test within 7 days of day 1 (D1) of treatment in women of child bearing potential
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or breastfeeding; women of child bearing potential must have a negative pregnancy test at screening
Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or breastfeeding - women of child bearing potential must have a negative pregnancy test at screening
Women of child-bearing potential who are pregnant or breastfeeding; women of child-bearing potential are defined as all women except women who are post-menopausal or who have had a hysterectomy; postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year
Women who are pregnant or breast feeding; a pregnancy test will be administered to women of child bearing potential (per institutional policies) at screening; women must agree to pregnancy tests prior to (up to 1 calendar day) each administration of a radionuclidic agent, including tracer doses, to be considered for this study
Negative urine or serum pregnancy test result for females of child bearing potential; females 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 23 weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than 1% per year for the duration of study participation and for a period of 31 weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that females of child-bearing potential use contraception for 5 half-lives plus 30 days and males who are the sexual partners of females of child-bearing potential use contraception for 5 half-lives plus 90 days; \r\n* Females must not be breast-feeding\r\n* Females of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab\r\n* A female of child-bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.; menopause is defined clinically as 12 months of amenorrhea in a female over 45 in the absence of other biological or physiological causes; in addition, females under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Females must be using adequate contraceptive measures, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
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.
Females of child bearing potential must have a negative serum pregnancy test within 14 days prior to entrectinib dosing
Obtained =< 14 days prior to registration: Negative pregnancy test for persons of child-bearing potential
Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001.
Women of child bearing potential (WOCBP) should use an adequate method to avoid pregnancy for 5 months plus the time required for nivolumab to undergo approximately five half-lives) after the last dose of investigational drug; in order for a woman to be determined not of child-bearing potential, she must have >= 12 months of non-therapy-induced amenorrhea or be surgically sterile
Men must agree to not donate sperm while on the study and for at least 3 months after the last dose of study drug(s); women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to the first administration of isatuximab and at the end of treatment visit; a negative urine pregnancy test is required prior to each subsequent isatuximab dose administration
Women of child-bearing potential must have a negative serum or urine pregnancy test.
Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
Women of child bearing potential must have a negative urine or blood pregnancy test within 14 days of study enrollment
Women must not be pregnant or breast-feeding\r\n* All female patients of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to treatment to rule out pregnancy \r\n* Pregnancy testing is not required for post-menopausal or surgically sterilized women
Negative beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Pregnant or lactating woman (as evaluated by serum testing within 48 hours of administration of the first vaccine in women of child bearing potential)
Women of child-bearing potential, who are biologically able to conceive, and not employing two forms of highly effective contraception; highly effective contraception must be used throughout the trial and up to 7 months after the last dose of study drug (e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device); women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ? 14 days prior to starting study drug
Women of child bearing potential: positive pregnancy test (serum)
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Female of child-bearing potential who is or has intention to be pregnant or breastfeeding.
Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration; patients with reproductive potential must agree to use an effective contraceptive method during treatment
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Women of child-bearing potential, defined as all women older than age 50 and anovulatory for 12 months, unless they are using highly effective methods of contraception during dosing and for 30 days after study treatment
Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
A negative pregnancy test (if female of child bearing potential); for men and women of child-producing potential, willingness to use effective contraceptive methods during the study
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
Women of child bearing potential (WOCBP) must use a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug; in order for a woman to be determined not of child-bearing potential, she must have >= 12 months of non-therapy-induced amenorrhea or be surgically sterile
Women of child-bearing potential (WOCBP), women who are pregnant, or women who are nursing
Meets one of the following criteria: Is post-menopausal, or, Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for four months after stopping medication.
Women of child bearing potential must have a negative pregnancy test; women of child-bearing potential are defined as all women except women who are post-menopausal or who have had a hysterectomy; postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year
Women of child-bearing potential who are pregnant or breastfeeding
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential that must be negative within 7 days of screening for the trial, pulmonary function tests and/or cardiac stress tests whose results are valid for 6 months if performed previously, unless there is an interval change in the patient’s clinical status determined by the Moffitt treating physician
Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 120 days after the last dose of investigational product
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential (WOCBP) must have a negative pregnancy test
Women of child bearing potential who are pregnant or breastfeeding; women with a positive pregnancy test at enrollment or prior to administration of vaccine
JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): \r\n* Women of child bearing potential who are pregnant or breastfeeding\r\n* Women with a positive pregnancy test prior to administration of vaccine
Women of child-bearing potential must have a negative urinary or serum pregnancy test
Negative pregnancy test for women with child-bearing potential
Females of child-bearing potential must have a negative serum pregnancy test within 7 days of treatment.
If the patient is a sexually active female of child bearing potential whose partner is male, or if the patient is a sexually active male whose partner is a female of child bearing potential, the patient must agree to use appropriate contraceptive measures for the duration of the treatment of the tumor and for 6 months afterwards; female patients of child bearing potential must have a negative serum pregnancy test within 48 hours of starting study treatment
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 5 months after the last dose of nivolumab for women, and 7 months after the last dose of nivolumab for men, and 6 months after the last dose of bevacizumab for subjects receiving bevacizumab
Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.
Women of child-bearing potential, unless they are using highly effective methods of contraception
Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal >= 1 year (yr)
Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential)
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Negative pregnancy test for women of child bearing potential
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Women of child bearing potential must have a negative pregnancy test by urinalysis
Women of child?bearing potential (e.g. not post?menopausal or permanently sterilized women) must have a negative pregnancy test obtained within 14 days prior to registration; this is to prevent potential harm to the fetus by glyburide and radiotherapy
Sexually active women of child-bearing potential must agree to use two forms of contraception prior to study entry and for the duration of study participation. A pregnancy test is required prior to study enrollment and monthly while on treatment with indoximod for all women of child- bearing potential. Also men should be discouraged from fathering children while on treatment.
Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
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
Women of child-bearing potential (ie, women who are premenopausal or not surgically sterile):
Women of child-bearing potential must have negative pregnancy test prior to initiating study drug treatment
Pregnant or lactating female: all females of child-bearing potential must have a negative serum pregnancy test within 7 days of treatment; lactating females must discontinue breast feeding
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
Women of child-bearing potential must have a negative pregnancy test
Pregnant or lactating – women of child bearing potential must have a negative pregnancy test within 14 days of study treatment start
Pregnant or nursing patients; women of childbearing potential must have a negative SERUM pregnancy test within 14 days of enrollment; women of child bearing potential must agree to use effective contraception for 14 days prior to enrollment, throughout the treatment period and for 4 to 6 months after the last dose of study treatment
Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Pregnant or lactating; adequate birth control must be used if of child bearing potential per institutional policy; negative pregnancy test in female patients of child-bearing potential per institutional policy; post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing
If the patient is a sexually active female of child bearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of child bearing potential, the patient must agree to use appropriate contraceptive measures for the duration of the treatment of the tumor and for 6 months afterwards as stated in the informed consent; female patients of child bearing potential must have a negative serum pregnancy test at the time of screening and within 48 hours of starting the D2C7-IT infusion
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
Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration; urine human gonadotropin (HCG) is an acceptable pregnancy assessment
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Women of child-bearing potential must have a negative serum pregnancy test =< 72 hours prior to initiating treatment
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
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
For females of child-bearing potential, negative serum pregnancy test at screening (within 48 hours prior to leukapheresis)
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Negative serum beta-HCG in females, and use of effective contraception in males and females of child-bearing potential, is required
Positive urine pregnancy test and/or breastfeeding; if a woman of child bearing potential or sexually active male, patient must be willing to use effective contraception throughout their participation in the treatment phase of the study
Women of child-bearing potential must have a negative pregnancy test at screening
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
Women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
Women of child-bearing age/potential and/or able to conceive
Pregnancy (positive pregnancy test) or lactation; use of effective means of contraception (men and women) in subjects of child-bearing potential
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child bearing potential only: Negative urine or serum pregnancy test
Subjects unwilling to use contraceptives if they have sexual intercourse with a female partner of child-bearing potential while receiving treatment on this study
DONOR: Female donors of child-bearing potential (> 7 yo) must have a negative serum or urine beta-HCG test within three weeks of marrow donation and agree to utilize contraception if sexually active
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to study registration
Pregnant or breast-feeding; urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain
Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Negative pregnancy test for women of child-bearing potential
Pregnancy: positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Women of child bearing potential not willing to use an effective contraceptive measure while on study
For women of child-bearing potential, negative serum pregnancy test within 14 days prior to registration
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Subjects of child bearing potential must have a negative urine pregnancy test within 5 days prior to first dose of the study drug
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Current or planned pregnancy or lactation in women of child bearing age (confirmed by negative pregnancy test prior to start of therapy)
Patients must not be pregnant; women of child-bearing potential must also have a negative pregnancy test within 2 weeks prior to start of protocol therapy (radiation and veliparib)
Use of effective means of contraception (men and women) in subjects of child-bearing potential
Women of child-bearing potential MUST have a negative serum or urine pregnancy test unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose
Negative pregnancy test (serum or urine) for women of child bearing potential; all protocol participants must agree to adequate contraception
Women of child-bearing potential must have a negative pregnancy test
For women of child bearing potential (women who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) a negative serum pregnancy test must be documented prior to initial registration
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.
Breast-feeding or pregnant; serum pregnancy test for women of child-bearing potential must be performed within 7 days prior to first dose of study treatment
Negative serum pregnancy test for women of child-bearing potential
Women of child-bearing potential must not be pregnant and must have a negative pregnancy test; men and women must agree to practice effective contraception while on this study
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
Pregnant women and women who are breast feeding are excluded; negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period; pregnancy testing will be carried out within two weeks prior to administration of radioiodinated 8H9 in females of childbearing age
Negative pregnancy test for women of child-bearing age
Not pregnant, and on appropriate birth control if of child-bearing potential
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Patients of child bearing potential should practice effective methods of contraception
Women Of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test (i.e., minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician(s) immediately. **Refer to pg. 10 of the protocol for the formal definition of a WOCBP.**
Women of child bearing age must be using adequate birth control and have a negative pregnancy test
Women of child-bearing age must be using adequate birth control and have a negative pregnancy test
Patients must not be pregnant or breast-feeding. Female patients of child-bearing potential must have a negative pregnancy test performed within 72 hours prior to randomization. Women of child-bearing potential must agree not to become pregnant while participating in the study.
Pregnant women are excluded; therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period
Patients who are pregnant; negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period
Lactating, breastfeeding, or positive pregnancy test for female patients of child-bearing potential.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment.
Female patients of child-bearing potential must agree to practice abstinence or use dual methods of contraception during treatment and for 30-days after the last dose of carfilzomib and have a negative serum pregnancy test at screening
If a female of child-bearing potential, has a negative serum pregnancy test result within 14 days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from 14 days before baseline (C1D1) through 30 days after the last study drug dose.
Females of child-bearing potential must have a negative pregnancy test within 7 days prior to registration
Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
Female subjects of child bearing age must have negative serum pregnancy test at study entry
Female patients of child-bearing potential must have a negative pregnancy test.
Pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
Child bearing age women with positive pregnancy test
Pregnant women or nursing mothers are not eligible for this trial; patients of child bearing potential must use adequate contraception
Negative urine or serum pregnancy test for females of child bearing potential within 7 days prior to registration\r\n* Females 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 23 weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than 1% per year for the duration of study participation and for a period of 31 weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that females of child-bearing potential use contraception for 5 half-lives plus 30 days and males who are the sexual partners of females of child-bearing potential use contraception for 5 half-lives plus 90 days\r\n* Females must not be breast-feeding\r\n* Females of child bearing 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\r\n* A female of child-bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a female over 45 in the absence of other biological or physiological causes; in addition, females under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Female of child bearing potential who is pregnant, is planning to become pregnant, or is breast feeding; or male who is sexually active with a female of child bearing potential who is planning to become pregnant.
Women who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test within 3 days prior to the start of study treatment.
Women of child-bearing potential MUST have a negative serum human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12 consecutive months of amenorrhea); subjects are considered not to be of child-bearing potential if they are surgically sterilized or post-menopausal (>=50 years of age and has not had menses for greater than 1 year or with serum follicle stimulating hormone (FSH) in the menopausal range will be considered postmenopausal); subjects should not become pregnant or breastfeed while on this study; sexually active subjects of child bearing potential must agree to use contraception for the duration of study participation and for 5 months after the last dose of ipilimumab or nivolumab
Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and continuing (23 weeks for females, 31 weeks for males) after the last dose of nivolumab
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. Men must agree not to father a child and agree to use a condom if his partner is of child-bearing potential.
Is a woman of child bearing potential (WOCBP) who are pregnant or nursing
Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first dose of abemaciclib
Women of child-bearing potential must attest to not being pregnant; pregnancy testing will be at the discretion of the treating physician
Negative pregnancy test in women of child bearing potential
Females of child-bearing potential* must have a negative pregnancy test.
Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential only
Negative serum pregnancy test result in women of child-bearing potential (WOCBP)
Negative pregnancy test for women with child-bearing potential
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
Negative serum pregnancy test result for females of child bearing potential
Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment
Pregnant females are excluded from this study; all females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration
Female patients of child-bearing potential or male patients with partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period.
Negative pregnancy test for women of child bearing potential
Evidence of non-child-bearing status for women of childbearing potential; negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1
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
All women of child-bearing potential who take ribavirin will need to have a negative pregnancy test
Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
Women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 days and again within 24 hours prior to beginning study treatment
Pregnant women are excluded from this study; females of child bearing potential must have a negative pregnancy test within 14 days of study treatment; breastfeeding must be discontinued before beginning fludarabine (fludarabine phosphate)
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 child bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Females of child-bearing potential must agree to ongoing pregnancy testing and to practice contraception as directed
For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or lactating – women of child bearing potential must have a negative pregnancy test within 14 days of study treatment start
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry (within 72 hours prior to initiation of study treatment) and be practicing an effective form of contraception; women should not breast-feed while on this study
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential which must be negative within 7 days of screening, human leukocyte antigen (HLA)-typing which will not be repeated if performed previously, and pulmonary function tests (PFTs)/cardiac stress tests whose results are valid for 6 months if performed previously
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential must be negative within 7 days of starting vemurafenib, human leukocyte antigen (HLA)-typing which will not be repeated if performed previously, and pulmonary function test (PFTs)/cardiac stress tests whose results are valid for 6 months if performed previously
For women of child bearing potential, a negative serum pregnancy testing will be verified within 14 days prior to pre chemotherapy apheresis
Female subjects who are pregnant intend to become pregnant or are nursing; female subjects with child-bearing potential must have a negative pregnancy test within one week of enrollment
Pregnant women or nursing mothers are not eligible for this trial; patients of child bearing potential must use adequate contraception
Females of child-bearing potential must have a negative pregnancy test
Women must: have a negative serum or urine pregnancy test within 7 days prior to study entry if she is a woman of child-bearing potential (WOCBP), or be at least one year post-menopausal, OR be surgically sterile
Pregnant (positive pregnancy test) or lactating women will be excluded from the study; also, unwillingness to use effective means of contraception in subjects with child-bearing potential will be excluded from the study; women of child-bearing potential must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation
Negative pregnancy test (serum or urine) within 10 days of registration in women of child-bearing potential
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
Pregnant (positive pregnancy test) or lactating; unwillingness to use effective means of contraception in subjects with child-bearing potential
Negative serum or urine pregnancy test for females of child bearing potential
All women of child bearing potential (WOCBP) should be instructed to contact the investigator immediately if they suspect they might be pregnant
Be of non-child bearing potential:
The participant, if female and of child-bearing potential, must have a negative pregnancy test.
If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
Negative pregnancy test for women of child bearing potential
Females with child-bearing potential must have had a negative serum pregnancy test result =< 28 days prior to the first dose of study treatment
Women should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test before start of dosing if of child-bearing potential or must have evidence of nonchildbearing potential.
If the subject is a woman of child-bearing potential or man who is sexually active with woman of child-bearing potential, the subject agrees to use adequate contraception from signing of the ICF, for the duration of study participation; and for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of IMP for men;
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CTL019 infusion.
MF PATIENTS: Female patients of child-bearing potential (FOCBP) must have a negative serum beta-HCG pregnancy test within 7 days prior to registration
Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months; OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy from screening until 3 months after their last dose of study medication
For women of child-bearing potential and for men with partners of child-bearing potential, subject must agree to take contraceptive measures for duration of treatments and 6 months after the last dose of BEV.
Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
men and women must agree to the use an effective method of contraception during the study and for at least 3 months post last dose of study drug administration. Women of child-bearing potential must have negative serum and urine pregnancy tests at screening and during each treatment cycle, respectively
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study participation
Patients with child bearing potential must agree to use adequate contraception
Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study (see below)
Females should agree to use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after completion of dosing.
Use of an effective means of contraception in subjects of child-bearing potential
Negative pregnancy test for all females of child bearing potential
In women of child-bearing potential, negative serum pregnancy test within 14 days of the first infusion of G-202
Woman of child-bearing potential has negative pregnancy test before the initiation of study drug dosing
Women of child bearing potential must have a negative serum pregnancy test.
If a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 2 weeks prior to treatment.
Men who are sexually active with women of child bearing potential must agree to use a condom from screening through 7 months after the last dose of study treatment (including nivolumab single agent).
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization are not considered to be of childbearing potential
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential
For women of child-bearing potential, a negative urine pregnancy test
If female of child-bearing potential, have a negative pregnancy test =< 14 days prior to registration
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after treatment completion
Women of child bearing potential must not be pregnant; a pre-study pregnancy test must be negative
Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization
Negative pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Females of child-bearing potential using contraception; negative pregnancy test
Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
The participant, if female and of child-bearing potential, must have a negative serum or urine pregnancy test within 7 days prior to randomization.
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who have a negative serum pregnancy test at study screening; a tubal ligation is sufficient documentation that a patient is not of child bearing potential; female patients of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after the last dose of either study drug
Pregnant and nursing women are excluded; men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy; women with child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening
Female patients are not of child bearing potential or if they are of child bearing potential, they must not be pregnant or breast-feeding
Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from study entry until 30 days after last dose of study drug; male partners should be instructed to use contraception during the study period; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; if a woman becomes pregnant or suspects she is pregnant while on study, she should tell her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling 1 of the following at screening: a) post-menopausal defined as > 50 years old and amenorrheic for >= 12 consecutive months following cessation of all exogenous hormonal treatments; b) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
Negative serum pregnancy test for women of child-bearing potential
Female patients of child bearing potential must have negative serum pregnancy test
Patients with child-bearing potential must have a negative urine pregnancy test within 7 days prior to registration
Pregnant or breast feeding women; women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
If female and of child-bearing potential, has negative pregnancy test within 14 days prior to treatment.
Pregnancy, or unwillingness to use contraception if they have child bearing potential
A negative serum pregnancy test obtained within 4 weeks prior to the start of treatment in all women of child-bearing potential
Of non-child bearing potential:
Women of child-bearing potential must have a negative (urine or blood) pregnancy test within 6 weeks prior to start of protocol therapy; women of child-bearing potential must also use effective non-hormonal contraception while undergoing radiation therapy
Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum follicle stimulating hormone (FSH) levels greater than 35 mIU/mL. A negative serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above
Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to registration
Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug; male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, or avoidance of intercourse during the study and for 6 months after last investigational drug dose received
Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant. (For patients with child bearing potential, a ?HCG must be completed within 14 days of first treatment).
Pregnant women, or women of child-bearing potential not using reliable means of contraception
Negative pregnancy test for women with child-bearing potential
Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.
For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after the treatment period
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 7 days prior to registration; effective contraception (men and women) must be used in patients of child-bearing potential while on study treatment and for 6 months after
Patient refuses to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential
In women of child-bearing potential, negative serum pregnancy test within 48 hours prior to day 1 of study treatment and agree to use effective contraception
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives; men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
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
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
Women of child bearing potential must undergo pregnancy testing within 7 days of the first dose of study therapy; women must also undergo pregnancy test at 6 months after the last dose
If a female of child bearing potential, willing to use adequate contraception (defined as double-method contraception, e.g. oral contraceptive usage by subject and condom by partner); non-child bearing potential is defined as being at least 2 years post-menopausal or being surgically sterile
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
Woman of child-bearing potential has negative pregnancy test before the initiation of study drug dosing
Negative urine pregnancy test within one week before starting treatment in women of child-bearing potential
Women must:\r\n* Have a negative serum or urine pregnancy test within 7 days prior to study entry if she is a woman of child-bearing potential, OR\r\n* Be at least one year post-menopausal, OR\r\n* Be surgically sterile
Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods
Negative pregnancy test in women of child-bearing potential
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
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding; a woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months
Pregnancy (positive pregnancy test) or lactation- breast feeding; lack of effective means of contraception (men and women) in subjects of child-bearing potential
Non-pregnant and not nursing; women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 14 days prior to study entry; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/mL); women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be 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, for the duration of study participation, and for 30 days after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Patients who are pregnant, nursing or of child-bearing potential
Pregnancy (positive pregnancy test) or lactation; (an effective means of contraception [men and women] in subjects of child-bearing potential must be used)
Negative pregnancy test if female of child-bearing potential. Fertile patients must use effective contraception*.
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Females with child bearing potential must have a negative serum pregnancy test within 3 days of the first dose of study drug
Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or breastfeeding; women of child bearing potential must have a negative pregnancy test within 14 days of study treatment start
Negative urine or serum pregnancy test done =< 7 days prior to randomization, for women of child bearing potential only
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 lactating females will be excluded from this trial; patients of child-bearing potential must use an effective form of contraception while on study
Pregnancy or breast-feeding (participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Barrier contraceptive precautions are to be used throughout the trial by all study participants of child bearing potential.
Female patients with child-bearing potential must have a negative serum or urine pregnancy test within 7 days of study enrollment; nursing mothers should discontinue nursing
Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 90 days following the last study drug administration
Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation; a woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization; a negative pregnancy test result will be required before any study drug is given
Women with child-bearing potential not using a reliable an appropriate contraceptive method
Patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol
Women of child bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or is of child-bearing potential; female subjects of child-bearing potential must agree to abstain from sexual activity or to use 2 medically approved contraceptive measures/regimens from the time of signing the informed consent form through 3 months after the treatment period
Pregnancy in women of child bearing potential (pregnancy test performed within 2 weeks of study entry)
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Women of child bearing potential having a positive urine or serum pregnancy test (hCG) at the time of pre-operative evaluation (within 7 days of surgery)
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
Pregnant women are excluded for fear of danger to the fetus; therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period
Women of child-bearing potential must have a negative pregnancy test
Subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Day 0.
Negative serum pregnancy test for women of child-bearing potential
Negative pregnancy test for women of child-bearing potential.
Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
Women of child bearing potential must have a negative pregnancy test and use reliable methods of contraception
Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant. (For patients with child bearing potential, a ?HCG must be completed within 14 days of first treatment).
Patients with child bearing potential must have a negative pregnancy test (urine or serum) prior to study treatment
Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception
Females who are pregnant or lactating may not participate in this study; females of child-bearing potential must have a negative pregnancy test before starting study agent; patients who have had a bilateral oophorectomy, hysterectomy, or are greater than 1 year since their last menses are not considered to be of child-bearing potential
Pregnant women, or women of child-bearing potential not using reliable means of contraception
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
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
A female subject is eligible to participate ifs she is of: Non-child bearing potential as described in the protocol; OR Child bearing potential and agrees to use effective contraception as described in the protocol, for an appropriate period of time (as determined by the product label) prior to the start of dosing to sufficiently minimize the risk of pregnancy and for at least 2 weeks (14 days) following the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment followed by negative urine or serum pregnancy test once every 4 weeks (prior to next dose cycle) thereafter.- Adequate organ system function as defined in the protocol. Part 2 Inclusion Criteria
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential will be required to undergo a negative pregnancy test prior to enrollment, and women who are currently pregnant will not be considered eligible
Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test\r\n* Women of child-bearing potential unless they are using highly effective methods of contraception throughout the study and for 30 days after study drug discontinuation
Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
Pregnant or lactating women; all pre-menopausal and peri-menopausal women should have a urine test for pregnancy within a week of starting therapy; all patients of child bearing potential should agree to use an effective contraceptive method
Females of child-bearing potential must have a negative serum test Participation in concurrent clinical trials
Women of child bearing potential not willing to use an effective contraceptive measure while on study
Females must be either non-child bearing potential or have a negative pregnancy test within 3 to 5 days prior to the first dose of study drug.
Women of child-bearing age must have a negative, quantitative serum pregnancy test =< 14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation)
Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
Women of child-bearing potential who are pregnant or breastfeeding
Pregnant and breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded; this applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months), or women on hormone replacement therapy with serum follicle stimulating hormone (FSH) levels greater than 35 mIU/mL; a negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential; male subjects must also agree to use effective contraception for the same period as above
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (?7 days prior to the first dose of Study drug) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug.
Women of child-bearing age must have a negative pregnancy test
Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods; men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Women of child-bearing potential who are pregnant or nursing (lactating)
Women of child bearing potential must have a negative serum pregnancy test
A female of child-bearing potential, must have two negative urine pregnancy test results within 10 to 14 days prior to starting the first dose of vaccine and Revlimid pre-transplant
For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
Of non-child bearing potential:
Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 72 hours prior to starting study drug or a urine pregnancy test shall be done on Day 1 of Cycle 1
Women of child bearing potential must have a negative pregnancy test
If female of child bearing potential, have a negative pregnancy test at screening
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment
Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to date of study entry; women who have had menses within the past 2 years, who have not had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy are considered to be of child-bearing potential; patients with elevated human chorionic gonadotropin (hCG) at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated 5-7 days later, or pregnancy has been ruled out by vaginal ultrasound
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.
Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study for 60 days after study drug discontinuation
Positive pregnancy test in women of child-bearing potential.
If female of child bearing potential, have a negative pregnancy test at screening
Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment and have a negative serum or urine pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days; men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Pregnant or lactating female or female of child-bearing potential not employing adequate contraception.
Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy
Serum pregnancy test for women of child bearing potential must be negative at entry into study
The patient is a woman of child bearing potential (WOCBP) who has had a negative serum or urine pregnancy test within 1 week prior to SL-401 treatment (intervals shorter than 1 week are acceptable if required by institutional guidelines).
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives; men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Women of child-bearing potential must have a negative pregnancy test within 14 days prior to commencement of study treatment
Women of child-bearing potential must use an effective form of contraception during study and for at least 6 months after completion of study treatment
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 .
Female patients who are pregnant or lactating or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test =< 72 hours before registration)
Not pregnant; if female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential must have a negative pregnancy test.
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:
Negative pregnancy test (urinary or serum beta-HCG) at screening (applicable to women of child bearing potential who are sexually active)
Females must either be of non-child bearing potential or have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.
Women of child bearing potential must not be pregnant; a pre-study pregnancy test must be negative
Pregnancy or lactation; all females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to starting study treatment
of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to use protocol specified methods of birth control while on study.
Pregnant or breast feeding females (a urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy)
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
Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
Females of child-bearing potential (FCBP)^2:
Of nonchild bearing potential:
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening; male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential throughout the study and for three months following the last dose of selinexor
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Women of child-bearing potential must have a negative pregnancy test
Women of child-bearing potential who are pregnant or breastfeeding
Pregnancy test for females of child-bearing potential
For women of child-bearing potential, negative serum pregnancy test within 14 days prior to registration
Female patients of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration.
Women of child-bearing potential must have a negative pregnancy test prior to initiating study treatment
Women of child bearing potential between the ages of 18 and 60 years of age must have a negative urine pregnancy test prior to undergoing simulation in preparation for radiation therapy to the pelvis
Negative serum/urine pregnancy test within 24 hours for females of child bearing age prior to surgery
Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy
Female patients of child bearing age who have a positive pregnancy test
Pregnant women and women of child-bearing potential are eligible for participation in this study
Pregnancy (positive pregnancy test) or lactation; use of effective means of contraception (men and women) in subjects of child-bearing potential
Female participants of child-bearing potential must have a negative urine or serum pregnancy test at the time of the screening visit
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomized to either therapeutic arms)
Women of child-bearing age must have a negative, quantitative serum pregnancy test =< 14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation)
Females of childbearing potential must not be pregnant or breastfeeding on admission for conditioning for SCT and a pregnancy test will be required for all females of child-bearing potential
If the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year
Pregnant or nursing women - women of child?bearing potential must have negative serum or urine pregnancy test
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
CHILD PARTICIPANTS:
Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
Female subjects of child bearing potential must have a negative pregnancy test prior to first dose of tocilizumab and must agree to practice effective contraception during the study
Pregnancy or lactation; negative pregnancy test is required within the screening window for women of child bearing potential
Women of child-bearing potential must have a confirmed negative pregnancy test result prior to enrollment
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men
Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or breastfeeding; women of child bearing potential must have a negative pregnancy test at screening
Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within 7 days before starting drug
In women of child-bearing potential (WOCBP), a negative serum pregnancy test within 72 hours prior to procurement and again 72 hours prior to infusion is required
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin
Patients who are not practicing adequate contraception if the participants are of child bearing potential
A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment
A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ?13 years of age).
Negative urine pregnancy test within 2 weeks of registration for women of child-bearing potential; women of child-bearing potential must have a documented negative pregnancy test and agree to use adequate contraception throughout the study period
Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
A negative urine pregnancy test is required for female participants of child bearing potential (?13 years of age).
Females of child bearing age must have a negative serum pregnancy test within 7 days of first dose of study drug
Females (of child bearing potential) and males (of child bearing potential) must be abstinent or agree to use birth control during the study
Of child-bearing age with intact reproductive organs
Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within 7 days before starting drug
Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential
Use of an effective means of contraception in women of child-bearing potential
Negative serum pregnancy test, if of child-bearing potential
Known pregnancy or breast feeding; pregnant women are excluded as the effects of 18F-FLT on the fetus are not known, and there is the potential for teratogenic or abortifacent effects; within 48 hours prior to a PET scan, a pregnancy test will be obtained in all female participants of child bearing potential to confirm non-pregnant status; because there is an unknown, but potential, risk of adverse effects in nursing infants, breastfeeding should be discontinued before the mother receives 18F-FLT
Negative serum pregnancy test for women of child bearing potential (WOCBP)
If a female of child-bearing potential, must have a negative pregnancy test
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
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 have a negative urinary or serum pregnancy test within 7 days of baseline imaging
Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
Women of child bearing potential must have a negative serum pregnancy test
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
PATIENT: If of child-bearing potential, must have a negative pregnancy test
Negative pregnancy test if female of child-bearing age
Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential
Women of child bearing potential with negative pregnancy test documented
Negative pregnancy test for women of child-bearing potential
Negative urine pregnancy test in women of child-bearing potential
Negative serum pregnancy test for females of childbearing age (11- 55 years) and/or lack child-bearing potential
Women of child bearing potential must not be pregnant or breastfeeding; a negative serum pregnancy test must be obtained in women with child bearing potential within 7 days of 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; on the day of the scan the staff will verify and record that the patient has not had unprotected intercourse and does not think that she is pregnant; a repeat serum pregnancy test will be done if the patient can’t verify this
Women who are pregnant, as well as those women who are breastfeeding, will be excluded from this study; as part of their routine preoperative testing, all women of child bearing age receive a pregnancy test; the research staff will follow up on these results in order to determine eligibility; women who have had a hysterectomy or have not had menses for > 24 months will not be required to undergo a pregnancy test; breastfeeding women will be excluded from this study
Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method.
Negative serum pregnancy test for women of child bearing potential
If a female of child-bearing potential, must have a negative pregnancy test
Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nNegative serum or urine pregnancy test within 24 hours for females of child bearing age
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nNegative serum or urine pregnancy test within 24 hours for females of child bearing age
Negative serum pregnancy test for females of child-bearing age (11-50 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy)
Pregnancy or breast feeding; a negative serum pregnancy test is required for all female subjects with child-bearing potential
Not pregnant; a negative serum pregnancy test is required for all female subjects with child-bearing potential
Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration
Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT
Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception.
Lactation or pregnant - women of child bearing potential will be excluded
Negative pregnancy test if of child-bearing age
Women of child-bearing age will be asked to undergo a pregnancy test prior to enrollment
If a female of child-bearing potential, must have a negative pregnancy test
Women of child bearing potential
Female patients undergoing optional 18F-MISO-PET scan cannot be pregnant or nursing, as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential; females of child-bearing potential are defined according to Food and Drug Administration (FDA) guidelines as women capable of becoming pregnant, including women on oral injectable or mechanical contraception, women who are single, women whose husbands have been vasectomized, or women whose husbands have received or are utilizing mechanical contraceptive devices; if the result of the pregnancy test is positive, the patient (female) will be withdrawn from the study prior to administration of study treatment
All female participants with child bearing potential cannot be pregnant or nursing, as confirmed by serum pregnancy test; further, if the female patient is of child-bearing potential, she must agree with use birth control, including oral, injectable or mechanical contraception, abstinence, or vasectomy for 30 days following pimonidazole administration; female patients who become pregnant within six months after receiving the study treatment will be followed through birth or termination of the pregnancy; the Investigator or designee must report all pregnancies to the Sponsor or Sponsor’s authorized representative immediately after becoming aware of the event
Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
If a female of child-bearing age, must have a negative pregnancy test
Patients of child-bearing potential must have a negative urine or serum pregnancy test
Non-pregnant and not nursing\r\n* Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to study entry; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/mL); women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child-bearing potential\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
BIODISTRIBUTION COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening
DYNAMIC COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening
Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 30 days after the last dose of study medication; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation; male partners should be instructed to use contraception during the study period
Patients must have evidence of non-child-bearing potential.
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.
Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
must be willing to use appropriate contraception if of child-bearing potential
Not be pregnant or become pregnant during the study if the participant is a woman of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile); documentation of pregnancy can be taken from the medical record
For women of child-bearing potential and for men with partners of child-bearing potential, patient must agree to take contraceptive measures for duration of treatments and for one month after last study treatment
Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication, and who have a negative serum or urine pregnancy test within 1 week prior to initial trial treatment.