[c09aa8]: / clusters / 9knumclustersv2 / clust_2051.txt

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Female participants who are already pregnant or lactating, or plan to become pregnant within months of the last dose of study drug are excluded. Female participants of childbearing potential must adhere to contraception guidelines. Female participants will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over years with a screening serum follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females.
Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause, defined as no menses for at least year AND either age ? years or follicle-stimulating hormone levels in the menopausal range.
Women of childbearing potential must have a negative serum pregnancy test; and additionally agree to simultaneously use at least methods of effective contraception or abstain from heterosexual intercourse from the time of signing consent, and until months after patients last dose of protocol-indicated treatment; periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception; women of child bearing potential (WOCBP) are defined as those not surgically sterile or not post-menopausal; if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for at least year in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential; postmenopausal status in females under years of age should be confirmed with a serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women
Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for days post last dose of study drug.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days prior to receiving first dose of study medication; and additionally agree to use at least two methods of birth control or abstain from heterosexual intercourse from the time of signing consent, and until months after patients last dose of study drug\r\n* WOCBP of childbearing potential are defined as those not surgically sterile or not post-menopausal (i.e. if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for months in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential)
Participant is pregnant, breast feeding or planning to become pregnant; (all participants of childbearing potential regardless of method of birth control must have a negative pregnancy test at baseline; a woman is considered not to be of childbearing potential is she has had a hysterectomy, bilateral oophorectomy, or if she is > years of age with >= years of amenorrhea)\r\n* Breastfeeding should be discontinued if the mother is treated with ACTOplus met XR
Have a negative serum pregnancy test result at screening (for females of child bearing potential (FCBP); not applicable to patients who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy, post-menopausal is defined as > months since last menstrual cycle)
Female subjects must have a negative urine or serum pregnancy test within hours prior to start of study treatment if of childbearing potential or be of non-childbearing potential; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible; non-childbearing potential is defined as:\r\n* >= years of age and has not had menses for > years\r\n* Amenorrheic for > years without a hysterectomy and oophorectomy and a follicle stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation \r\n* Post-hysterectomy, oophorectomy, or tubal ligation; documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound; tubal ligation must be confirmed with medical records of the actual procedure
Female subjects of childbearing potential must have a negative serum pregnancy test within days of the first administration of study drug. For the purpose of this study, female subjects of childbearing potential are defined as all female subjects after puberty unless they are postmenopausal for at least year, or are surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation).
Females of childbearing potential must have a negative urine or serum pregnancy test within days of (cycle day [CD]) and have adequate contraception; (a female is considered to be NOT of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for consecutive months)
Female patients of childbearing potential must agree to use at least two methods of acceptable contraception with a failure rate of < % per year from days prior to first trial treatment administration until at least months after study participants final dose of study drugs.\r\n* Note: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for months without an alternative medical cause). Post-menopausal status in females under years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women.
For female subjects of childbearing potential, willingness to use an effective method of contraception from the start of the screening period until ? months after the last dose of cirmtuzumab and ? month after the last dose of ibrutinib, whichever is later. Note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone [FSH] levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin [beta HCG]); or is menopausal (age ? years with amenorrhea for ? months).
Female subjects of childbearing potential must have a negative pregnancy test at screening; childbearing potential is defined as: participants who have not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus)
Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least days after the last dose of assigned treatment. Female patients who are not of childbearing potential (permanently sterilized or postmenopausal; i.e., meet at least one of the following criteria):\r\n* Have undergone a documented hysterectomy and/or bilateral oophorectomy; or\r\n* Have medically confirmed ovarian failure; or\r\n* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level within the laboratorys reference range for postmenopausal women
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days prior to receiving first dose of protocol-indicated treatment; and additionally agree to use at least methods of acceptable contraception or abstain from heterosexual intercourse from the time of signing consent, and until months after patients last dose of protocol-indicated treatment; WOCBP of childbearing potential are defined as those not surgically sterile or not post-menopausal (i.e. if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for months in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential); postmenopausal status in females under years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women
If a female of childbearing potential, has a negative serum blood pregnancy test during screening and a negative urine pregnancy test within days prior to receiving the first dose of study drug; if the screening serum test is done within days prior to receiving the first dose of study drug, a urine test is not required; Note: Women of childbearing potential (WoCP) are any women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation; permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion; WoCP include non-women who have experienced menopause onset < months prior to enrollment
Female patient has a negative serum pregnancy test within days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through days after the last dose of study treatment, or is of non-childbearing potential; non-childbearing potential is defined as follows (by other than medical reasons):\r\n* >= years of age and has not had menses for > year\r\n* Patients who have been amenorrhoeic for < years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\r\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation; documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound; tubal ligation must be confirmed with medical records of the actual procedure; otherwise the patient must be willing to employ methods to avoid pregnancy; abstinence is an acceptable method to avoid pregnancy if this is the established and preferred method for the patient; alternatively, the patient and partner must use adequate barrier methods throughout the study, starting with the screening visit through days after the last dose of study treatment; information must be captured appropriately within the sites source documents\r\n** Male patients must also agree to use an adequate method to avoid pregnancy, which may include abstinence, if this is the established and preferred method for the patient starting with the first dose of study treatment through days after the last dose of study treatment.\r\n** Additionally, the participants must agree to not breastfeed during the study or for days after the last dose of study treatment
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 > years since last menstruation
if a woman of childbearing potential (WOCP), not be pregnant (confirmed by a negative serum pregnancy test within days of study entry and re-confirmed by a urine pregnancy test on the morning of Study Day , prior to the start of study treatment) and/or not be breast-feeding; [Note: Women who are postmenopausal for at least year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are not considered to be a WOCP.]
Female patients of childbearing age must have a negative serum HCG test within days of study enrollment, unless prior hysterectomy or menopause (defined as age ? years and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study.
Women of childbearing potential must have a negative serum pregnancy test within hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\r\n* Have undergone a documented hysterectomy and/or bilateral oophorectomy\r\n* Have medically confirmed ovarian failure; or\r\n* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratorys reference range for postmenopausal women
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within days prior to study registration and/or within hours of first dose of study drugs; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; female subjects will be considered of childbearing potential unless they are either:\r\n* Postmenopausal--defined as at least months with no menses without an alternative medical cause; in women < years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of months of amenorrhea, a single FSH measurement is insufficient; OR\r\n* Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least weeks prior to screening; OR\r\n* Have a congenital or acquired condition that prevents childbearing
If a female of childbearing potential, negative serum blood pregnancy test during screening and a negative urine pregnancy test =< days prior to receiving the first dose of study drug; if the screening serum test is done =< days prior to receiving the first dose of study drug, a urine test is not required\r\n* Non-childbearing potential is defined as (by other than medical reasons):\r\n** >= years of age and has not had menses for > years\r\n** Amenorrhoeic for < years without a hysterectomy and/or oophorectomy and a follicle stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\r\n** Post hysterectomy, oophorectomy or tubal ligation; documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound; tubal ligation must be confirmed with medical records of the actual procedure
Serum or urine pregnancy test must be negative in women judged premenopausal within days of randomization, or in women with amenorrhea of less than months at time of randomization; pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Fertile men or women of childbearing potential unless ) permanently sterile or ) using a highly effective measure of contraception such as condoms in males and consistent and correct use of one of the following in females: intrauterine device, tubal sterilization, Essure micro-insert system, vasectomy in the male partner; effective contraception is required for males during treatment with study drug and to continue for months after the last dose of either entospletinib or obinutuzumab, whichever is later; for women, effective contraception is required to continue for >= months after the last dose of obinutuzumab or for days after the last dose of entospletinib, whichever is later; for men, effective contraception is required to continue for months after the last dose of obinutuzumab treatment\r\n* Definition of childbearing potential: for this study, a female subject is considered of childbearing potential until becoming post-menopausal unless permanently sterile or with medically documented ovarian failure; women are considered to be in a postmenopausal state when >= years of age with cessation of previously occurring menses for >= months without an alternative cause; women of any age with amenorrhea of >= months may also be considered post-menopausal if their follicle stimulating hormone (FSH) level is in the post-menopausal range and they are not using hormonal contraception or hormonal replacement therapy; permanent sterilization in females includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a female subject of any age; permanent sterilization in males include bilateral orchiectomy or medical documentation of alternative explanation
Female patients of childbearing potential and male patients able to father children who have female partners of childbearing potential must agree to use one highly effective method (defined as less than % failure rate per year) and one additional effective method of contraception from days prior to first trial treatment administration until at least days after study participants final dose of avelumab; females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for months without an alternative medical cause); post-menopausal status in females under years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women; male patients able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy)
Women of childbearing potential must have a negative pregnancy test (or serum) within days prior to registration; (Note: contraception in patients with reproductive capacity will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years)
Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within days before the first dose of WT-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT-specific T cells will be counseled to use effective birth control during participation in this study and for months after the last T cell infusion
DONOR: Female subjects must have a negative urine or serum pregnancy test within days prior to taking study medication if of childbearing potential or must be of non-childbearing potential; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible; non-childbearing potential is defined as:\r\n* >= years of age and has not had menses for > years\r\n* Amenorrheic for > years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation\r\n* Post-hysterectomy, oophorectomy, or tubal ligation
Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-childbearing potential; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible; non-childbearing potential is defined as:\r\n* >= years of age and has not had menses for > years\r\n* Amenorrheic for > years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation\r\n* Post-hysterectomy, oophorectomy, or tubal ligation
If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to weeks following the study treatment\r\n* For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)
Women of childbearing potential are defined as follows: having regular menstrual cycles; has amenorrhea, irregular menstrual cycles or using a contraceptive method that precludes withdrawal bleeding; have had a tubal ligation; women are considered not to be of childbearing potential for the following reasons: had hysterectomy and/or bilateral oophorectomy; post-menopausal defined by amenorrhea for at least year in a woman > years old
Pregnant or breastfeeding; if sexually active and with childbearing potential, must agree to use effective method of contraception, such as intrauterine device, bilateral tubal ligation for >= months before randomization, partner vasectomized for >= months before randomization, and sexual abstinence when in relation to the preferred and usual lifestyle of the subject; male subjects must use a condom when having sex with a pregnant woman and when having sex with a woman of childbearing potential from the time of the first dose of study drug through days after the last dose of study drug; contraception should be considered for a nonpregnant female partner of childbearing potential; male subjects with partners of childbearing potential must use a condom and contraception should be considered for the female partner from the time of the first dose of study drug through days after the last dose of study drug; male subjects whose partners are pregnant should use condoms for the duration of the pregnancy\r\nMale and female subjects must agree not to donate sperm or eggs, respectively, from the first dose of study drug through days and days after the last dose of study drug, respectively (hormonal contraception is not allowed) prior to study entry, during treatment, and for days after last dose of study drug; females considered not of childbearing potential include those who are surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy) or who are post menopausal, defined as: < years of age with no spontaneous menses for >= months before randomization and with a postmenopausal follicle stimulating hormone (FSH) concentration > IU/L (or meeting criteria for post-menopausal status by the local laboratory)\r\nIf females with childbearing potential, a negative serum pregnancy test at screening and willing to have additional serum and urine pregnancy tests during the study [Note: Females without childbearing potential include those in menopause >= years, with tubal ligation >= year before screening, or with total hysterectomy]
Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least weeks prior to study entry, for the duration of study participation, and for at least months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least mIU/mL) within days prior to the first dose of GDC- (serum or urine); a pregnancy test (serum or urine) will be administered every weeks if their menstrual cycles are regular or every weeks if their cycles are irregular while on study within the -hour period prior to the administration of GDC-; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-, the investigator must confirm and document the patients use of two contraceptive methods, dates of negative pregnancy test, and confirm the patients understanding of GDC- cause serious or life-threatening birth defects; patients must continue highly effective contraception during therapy and for months after the last dose of GDC-\r\n* Women of childbearing potential are defined as follows:\r\n** Patients with regular menses\r\n** Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Women who have had a tubal ligation\r\n* Women are considered not to be of childbearing potential for the following reasons:\r\n** The patient has undergone hysterectomy and/or bilateral oophorectomy\r\n** The patient is post-menopausal defined by amenorrhea for at least months in a woman > years old\r\n* Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with GDC- and for months after the last dose to avoid exposing an embryo or fetus to GDC-
Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least weeks prior to study entry, 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; women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least mIU/mL) within - days prior to the first vaccine, within hours prior to the first and second doses of vaccine and prior to surgery\r\n* Women of childbearing potential are defined as follows:\r\n** Patients with regular menses\r\n** Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Women who have had a tubal ligation\r\n* Women are considered not to be of childbearing potential for the following reasons:\r\n** The patient has undergone hysterectomy and/or bilateral oophorectomy\r\n** The patient is post-menopausal defined by amenorrhea for at least year in a woman > years old
Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test result within days before the first dose of WT-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT-specific T cells will be counseled to use effective birth control during participation in this study and for months after the last T cell infusion
Female subjects of childbearing potential must have a negative serum human chorionic gonadotropic (hCG) test within week of Day (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are > year post-menopausal); and
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within days of registration; the patient and her sexual partner(s) must agree to use adequate contraception when sexually active for the duration of the study and for months after finishing study drug; a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy; a postmenopausal state is defined as no menses for months without an alternative medical cause; a high follicle stimulating hormone (FSH) level in the postmenopausal range maybe used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy
Patients with childbearing potential who are not willing to use adequate contraception precautions during the study and for months after stopping study chemotherapy\r\n* Women of childbearing potential (and men) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients of childbearing age will be required to have a negative pregnancy test within a week prior to consenting for study\r\n* All women are considered of childbearing potential, unless they meet at least one of the following criteria:\r\n** Females who are menopausal, defined as follows: i) females who are younger than years old will be considered menopausal if they satisfy all the following three requirements during screening: ) they are in amenorrhea, defined as absence of menstruation for the previous months; ) they have a negative urine pregnancy test; and ) they have a serum follicle-stimulating hormone (FSH) level within the laboratory reference range for postmenopausal females; ii) females who are older than years old: they will be considered menopausal if they are in amenorrhea, defined as absence of menstruation for the previous months before screening\r\n** Females who have a documented hysterectomy and/or bilateral oophorectomy and/or tubal ligations\r\n* All men are considered of childbearing potential, unless they meet at least one of the following criteria:\r\n** Males who have a documented vasectomy more than months prior to the administration of the first study treatment.\r\n** Female partner/partners who are menopausal (as previously defined) and/or who have a documented hysterectomy and/or bilateral oophorectomy and/or tubal ligations
All women of childbearing potential (WOCBP) must have a negative pregnancy test within days of the first dose of study therapy. A woman is not of childbearing potential if she has undergone surgical sterilization (bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy) or if she is ? years of age and has had no menstrual bleeding of any kind including menstrual period, irregular bleeding, spotting, etc., for at least months and there is no other cause of amenorrhea (e.g., hormonal therapy, prior chemotherapy).
Negative pregnancy test (serum or urine) for women of childbearing potential (WOCBP) Women considered not of childbearing potential include any of the following: no menses for at least years or menses within years but amenorrheic for at least months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least months or with bilateral tubal ligation
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within weeks prior to registration\r\n* Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
For men and women of child-producing potential, willingness to use effective contraceptive methods during the study. If female (or female partner of male patient), was either not of childbearing potential (defined as postmenopausal for ? year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing one of the following medically acceptable methods of birth control and agreed to continue with the regimen throughout the duration of the study:
Negative serum or urine pregnancy test for women within days of receiving the first dose of the study medication for women of childbearing potential; women will be considered not of childbearing potential and exempt from pregnancy testing if they are either a) older than and amenorrheic for at least consecutive months following cessation of all exogenous hormonal treatments, or b) have 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 serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (>= year before screening), total hysterectomy or menopause (defined as consecutive months of amenorrhea); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use dual contraception for the duration of study participation and for days after the last dose of talazoparib
REGISTRATION EXCLUSION CRITERIA: Pregnant or breastfeeding; patient must have a negative serum pregnancy test =< days from date of registration (if a woman of childbearing potential)\r\n* Women of childbearing potential are defined as follows:\r\n** Women with regular menses\r\n** Women with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Women who have had a tubal ligation\r\n* Women are considered not to be of childbearing potential for the following reasons:\r\n** The patient has undergone hysterectomy and/or bilateral oophorectomy\r\n** The patient is post-menopausal defined by amenorrhea for at least year in a woman > years old
Females of childbearing potential must have a negative pregnancy test within days of the start of treatment and on Day before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as > years of age and without a menstrual period for consecutive months
Female subjects of childbearing potential must adhere to contraception guidelines as outlined in the protocol. Female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for more than years with a screening serum follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females
Male or non-childbearing potential females, (female patients who meet at least one of the following criteria are defined as women of non-childbearing potential)\r\n* >= years old and naturally amenorrheic for >= year\r\n* Permanent premature ovarian failure confirmed by specialist gynecologist\r\n* Previous bilateral salpingo-oophorectomy or hysterectomy\r\n* XY karyotype, Turners syndrome, or uterine agenesis
Women of child-bearing potential must have a negative serum pregnancy test within days prior to date of study entry; women who have had menses within the past 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 - days later, or pregnancy has been ruled out by vaginal ultrasound
Female patients of childbearing potential must have a negative serum pregnancy test. Sexually active patients must be willing to use non-hormonal contraception, including condom use by male partner, and barrier method by the female partner during the treatment period and for at least months after the last dose of the study drug. Females considered not of childbearing potential include those who have been in menopause > years, or are surgically sterile (status post tubal ligation or hysterectomy).
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, then she must practice adequate contraception for days prior to treatment administration, have a negative pregnancy test and continue such precautions for months after completion of the treatment administration series.
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate con-traception for days prior to treatment administration, have a negative pregnancy test and continue such pre-cautions for two months after completion of the treatment administration series.
Being female and pregnant, breast-feeding or of childbearing potential; (note: lack of childbearing potential for female patients is satisfied by: a) being post menopausal; b) being surgically sterile; c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the duration of the study; or d) being sexually inactive; confirmation that the patient is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of enrollment
Negative pregnancy test; women of childbearing potential (not having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > year) must agree to use documented reliable method(s) of contraception; men should agree to use condoms during the study period
For women of childbearing potential; negative pregnancy testing within hours prior to or on study visit # (day ) and willingness to use adequate contraception during the study intervention; OR post-menopausal defined as any one of the following ) prior hysterectomy, ) absence of menstrual period for year in the absence of prior chemotherapy or ) absence of menstrual period for years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; in women of childbearing potential, effective contraception must be used for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously; If participants are interested in enrolling and have not met the requirement for contraception, they will be seen in the clinic in month for re-evaluation once they have met this requirement and ensure all other eligibility criteria is met prior to dose assignment
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Females: \r\n* Of childbearing potential must: \r\n** Not be nursing\r\n** Have a negative serum pregnancy test documented within hours prior to administration of F FSPG PET/CT\r\n* Not of childbearing potential must be: \r\n** Physiologically postmenopausal (cessation of menses for more than year)\r\n** Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the F-FSPG or the F-FDG PET/CT scans in accordance with the standard policy of the Medical Imaging Service at our facility; women who have experienced consecutive months of amenorrhea, have reached at least years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the hour period immediately prior to administration of Zr-trastuzumab) is negative