[c09aa8]: / clusters / 9knumclustersv2 / clust_1485.txt

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Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for days following the last dose of study drug; women of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for days following the last dose of study drug
Female subjects of reproductive potential (FSRP) must have a negative urine or serum pregnancy test. NOTE: FSRP is defined as premenopausal and not surgically sterilized. FSRP must agree to use maximally effective birth control or to abstain from heterosexual activity throughout the study, starting at the first dose of chemotherapy for at least months after receiving the T-cell infusion, or months after there is no evidence of persistence/ gene modified cells in the subject's blood, whichever is longer. FSRP randomized to Arm must use effective contraception for at least months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells.
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 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 ? year.
For females of childbearing potential (defined as < years after last menstruation or not surgically sterile), a negative serum pregnancy test must be documented in the days before the first dose of study treatment For females who are not postmenopausal ( months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, during the study treatment period and for at least months after the last dose of study treatment For males: agreement to use a barrier method of contraception during the study treatment period and for at least months after the last dose of study treatment
Patients of childbearing potential must have a negative serum pregnancy test within days prior to the study entry and be practicing an effective form of contraception
Women of childbearing potential must have a negative serum pregnancy test within days prior to randomization and agree to use effective contraception
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception up until three months after of receiving the last drug treatment
Female subject of childbearing potential (ie, premenopausal or not surgically sterile) must agree to use effective contraception from Day until days after the last dose of study drug, and have a negative serum or urine pregnancy test within weeks prior to Day . Sexually active male subjects must also use effective contraception from Day until days after the last dose of any study drug.
Pregnancy or lactation. Pregnancy is associated with considerable immune suppression and this additional parameter may interfere with the evaluation of dendritic cell induced immune responses in melanoma study subjects. Pregnancy test must be negative on all women of reproductive potential at baseline (within days of entry into the study) and they must agree to use birth control measures while on the study
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method during the study and for months after last study drug administration
STRATUM A: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for weeks after discontinuation of the study drug
STRATUM B: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for weeks after discontinuation of the study drug
STRATUM C: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for months after discontinuation of the study drug
Women of child-bearing potential must have a negative serum pregnancy test within hour of initiation of dosing and must agree to use an effective form of contraception during the study from the time of the negative pregnancy test up to 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-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= year; fertile men must also agree to use an effective method of birth control while on study drug and up to months after the last dose of study drug
Women of childbearing potential must have negative pregnancy test performed within days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for months after the last dose of study drug. Infusion sub-study prior therapy requirements: Same as above, except:
Female patients of childbearing potential must have a negative serum or urine pregnancy test within days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of months following the last dose of study drug. Post-menopausal females (> years old and without menses for > year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of months following the last dose of study drug if sexually active with a female of childbearing potential
Pregnancy and contraception:\r\n* Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential\r\n* Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least days after last avelumab treatment administration if the risk of conception exists
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (? days prior to st study drug dose) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 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 ? year.
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
Female subjects of childbearing potential must not be pregnant at screening; female patients must be either postmenopausal, free from menses for >= years, surgically sterilized, or willing to use two adequate barrier methods of contraception to prevent pregnancy, or must agree to abstain from heterosexual activity throughout the study; female patients of childbearing potential must have a negative serum (beta human chorionic gonadotropin [?HCG]) or urine pregnancy test before receiving the first dose of cabozantinib or carfilzomib; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of reproductive potential will be counseled to use effective contraceptive\r\nmeasures to prevent pregnancy during treatment with either cabozantinib or carfilzomib; patients shall be advised not to take cabozantinib or carfilzomib treatment while pregnant or breastfeeding; if a patient wishes to restart breastfeeding after treatment, she will be advised to discuss the appropriate timing with her physician
Females of child bearing potential must have a negative serum pregnancy test with days prior to first dose of treatment; female patients of childbearing potential and all male partners must agree to use double barrier methods of contraception throughout the study period and for at least days following investigational product discontinuation
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-human chorionic gonadotropin [hCG]) pregnancy test result within days prior to the first dose of study drugs and must agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for days after the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal (defined as absence of menses for >= year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for days following the last dose of study drug
Women of childbearing potential must have a negative serum pregnancy test within days prior to cycle day and agree to use effective contraception, throughout the treatment period, and for months after the last dose of study treatment
Female patients of childbearing potential must have a negative serum or urine pregnancy test within days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of months following the last dose of study drug. Post-menopausal females (>= years old and without menses for >= year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of months following the last dose of study drug if sexually active with a female of childbearing potential
Men must agree to not donate sperm while on the study and for at least months after the last dose of study drug(s); women of child bearing potential must have a negative serum pregnancy test result within 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 childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception during the study and for days following the last dose of study treatment.
A willingness to avoid pregnancy or fathering children in male and female subjects respectively:\r\n* A woman of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and must be willing to avoid pregnancy during the treatment period and for a specified duration ( year post hematopoietic cell transplant [HCT]) after the end of treatment\r\n* Women of childbearing potential who have a negative serum pregnancy test at screening must practice a highly effective method of birth control (with at least % certainty) from screening through safety follow-up; permitted methods that are at least % effective in preventing pregnancy should be communicated to the subject and their understanding confirmed\r\n* Men who are enrolled must agree to take appropriate precautions to avoid fathering children (with at least % certainty) from screening through safety follow-up; permitted methods that are at least % effective in preventing pregnancy should be communicated to the subject and their understanding confirmed
Female patients of childbearing potential must have a negative serum or urine pregnancy test within days prior to the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of months following the last dose of study drug; post-menopausal females (> years old and without menses for > year) and surgically sterilized females are exempt from these requirements; male patients must use an effective barrier method of contraception during the study and for a minimum of months following the last dose of study drug if sexually active with a female of childbearing potential
PHASE II: Female patients of childbearing potential must have a negative serum or urine pregnancy test within days prior to the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of months following the last dose of study drug; post-menopausal females (> years old and without menses for > year) and surgically sterilized females are exempt from these requirements; male patients must use an effective barrier method of contraception during the study and for a minimum of months following the last dose of study drug if sexually active with a female of childbearing potential
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within days prior to the first dose of treatment and must agree to use an effective contraception method during the study and for months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for months following the last dose of study drugs
Persons of reproductive potential must agree to an adequate method of contraception throughout treatment and for at least weeks after study drug is stopped\r\n* Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to start of study drug administration
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for days following the last dose of study drug; women of non- childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for days following the last dose of study drug
Have a negative serum pregnancy test within days of study treatment and confirmed prior to treatment on Day , and agree to use contraception if they or their partner are of reproductive potential
Pregnant or lactating patients; patients of childbearing potential must agree to avoid pregnancy during study treatment and for at least two weeks after the last dose of the study drug
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for days following the last dose of study drug; women of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for days following the last dose of study drug
Women of childbearing potential (defined as not postmenopausal [ie, ? months of non-therapy-induced amenorrhea] or not surgically sterile) must have a negative serum pregnancy test within days prior to initiation of Toca , and be willing to use an effective means of contraception in addition to barrier methods (condoms).
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-hCG) pregnancy test result within hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for weeks after the last dose of the study drug; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy
Female patients of childbearing potential must have a negative serum or urine pregnancy test within days prior to CD and agree to use dual methods of contraception during the study and for a minimum of days following the last treatment. Post menopausal females (> years old and without menses for > year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of days following the last treatment if sexually active with a female of childbearing potential.
Patients of childbearing potential must have a negative serum pregnancy test within weeks prior to CRS and must be practicing an effective form of contraception during the study period
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; if applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for weeks following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for weeks following the last dose of study drugs
Pregnant or nursing patients; women of childbearing potential must have a negative SERUM pregnancy test within days of enrollment; women of child bearing potential must agree to use effective contraception for days prior to enrollment, throughout the treatment period and for to months after the last dose of study treatment
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for days following the last dose of study drug; effective methods of birth control include: birth control pills, shots, implants (placed under the skin by a health care provider) or patches (placed on the skin); intrauterine devices (IUDs); condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy
Patients of childbearing potential must have a negative serum pregnancy test within days of treatment; patients must agree to use a reliable barrier method of birth control during and for months following the last dose of study drug
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method during the study and for months after last study drug administration
If female and of childbearing potential, have a negative serum or urine pregnancy test during screening. Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least weeks after treatment.
Women of child-bearing potential MUST have a negative serum or urine pregnancy test unless prior hysterectomy or menopause (defined as 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 days after the last dose
Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through days after the last dose of study medication; 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 post-menopausal for > year\r\n* Note: Female subjects of childbearing potential must have a negative urine or serum pregnancy test within days prior to receiving therapy; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum or urine pregnancy test for women of childbearing potential within weeks prior to the first dose of study treatment, preferably as close to the first dose as possible. Patients of childbearing potential must agree to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning weeks before the first dose of investigational medicinal product (IMP) and for days after the final dose of IMP.
Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days of treatment and must practice an effective method of contraception during treatment and for at least months ( days) following the last dose of study drug.
If a female of child-bearing potential, has a negative serum pregnancy test result within days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from days before baseline (CD) through days after the last study drug dose.
Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for months after the last treatment intake
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until months after the last dose of study medication
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within days of the first dose of study drug and agree to use dual methods of contraception during the study and for month following the last dose with study drug. Post menopausal females (> years old and without menses for > year) and surgically sterilized females are exempt from this criterion.
Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from weeks prior to the study and until month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within days prior to the start of study treatment; male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for months after treatment stops
For female subjects of childbearing potential, willingness to abstain from heterosexual intercourse or use concurrent protocol recommended methods of contraception from the screening visit throughout the study treatment period and to days from the last dose of pembrolizumab; a negative serum pregnancy test is required for female subjects at screening; lactating females must agree to discontinue nursing before administration of study drugs
If female: not breastfeeding; agrees to not attempt to become pregnant during the study; is surgically sterile or at least -years postmenopausal, or if of childbearing potential, has negative screening serum pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within hours.); if of childbearing potential (including being < years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, barrier methods, barrier method plus hormonal method) during treatment and for ? days after the last dose of any study therapy (IV or oral)
Women of childbearing potential must have a negative serum pregnancy test within days prior to randomization and must agree to use effective contraception throughout the treatment period and for months after the last dose of study treatment
Female patients of childbearing potential must have a negative pregnancy test and agree to use two forms of acceptable contraceptive measures from the time of consent through days after discontinuation of study drug administration.
Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry (within hours prior to initiation of study treatment) and be practicing an effective form of contraception; women should not breast-feed while on this study
Females of childbearing potential must:\r\n* Agree to using a reliable form of contraception (eg, oral contraceptives, intrauterine device, double barrier method of condom and spermicidal) for at least days prior to the first dose of any study drug, during the treatment period (and treatment/follow-up if receiving study drug), and for at least days after the last dose of any study drug\r\n* Have a negative serum beta-human chorionic gonadotropin (beta-HCG) at screening
Females of childbearing potential must:\r\n* Agree to use using a reliable form of contraception (e.g., oral contraceptives, intrauterine device, double barrier method of condom and spermicidal) for at least days prior to the first dose of any study drug, during the treatment period (and treatment/follow-up if receiving study drug), and for at least days after the last dose of any study drug\r\n* Have a negative serum beta (B)-human chorionic gonadotropin (B-HCG) at screening
If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least months after completion of study therapy
Patients of childbearing potential must have a negative serum pregnancy test within days prior to the study entry and be practicing an effective form of contraception
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
negative serum pregnancy test at baseline (within days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for weeks following the last dose of abemaciclib id menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least days after the last dose of investigational product
Female patients of childbearing age must have negative urine or serum pregnancy test; subjects agree to use an acceptable method for contraception during the entire study treatment period and through months after the last dose of brentuximab vedotin
Pregnancy Prevention Patients of childbearing or child fathering potential must use a highly effective method of contraception throughout the study while taking the drug and for days after stopping treatment
Female who has been post-menopausal for more than one () year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than % failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) Female of childbearing potential must have a negative from Screening until days after last dose of INTUVAX and/or until completed sunitinib treatment whichever occurs later.blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one () day before each dose of Intuvax) and must not be lactating.
Patients of childbearing potential must have a negative blood pregnancy test within days of treatment; patients must agree to use a reliable barrier method of birth control during and for months following the last dose of study drug
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception, during the study and for days following the last dose of study treatment.
A woman of childbearing potential who agrees to use a highly effective contraception (i.e., methods with a failure rate of less than % per year) as detailed in in Appendix VII of this protocol weeks before start of first dose of study treatment, during the treatment period and for at least weeks after the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test (?-HCG test in serum) prior to enrollment.
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for days following the last dose of study drug; effective methods of birth control include: \r\n* Birth control pills, shots or implants (placed under the skin by a health care provider) or patches (placed on the skin);\r\n* Intrauterine devices (IUDs); \r\n* Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy
Have negative serum pregnancy test within days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for weeks following last dose of study treatment.
Patient of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing and effective form of birth control
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for weeks ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy
Or, if of childbearing potential: must have a negative urine pregnancy test at Screening and on Day before the first dose of study drug is administered, and must use acceptable methods of birth control* if sexually active from Screening through months after the last dose of study drug.
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for weeks following the last dose of study drugs
Patients of childbearing potential must have a negative serum pregnancy test within days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
Women of childbearing potential (less than consecutive months since last regular menses, or surgically sterile) must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test and must agree to use hormonal, intrauterine device (IUD), or barrier birth control with spermicide to avoid pregnancy during the study; agreement to participate in this study via the informed consent will indicate subjects commitment to subject avoid pregnancy in self or a partner of childbearing potential for up to months after the last dose of study therapy
Patients of childbearing potential must have a negative serum pregnancy test within days of treatment; patients must agree to use a reliable method of birth control during and for months following the last dose of study drug
Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use adequate methods of contraception starting with the screening visit through days after the last dose of pembrolizumab
Women of childbearing potential must have a negative serum pregnancy test within days prior to the first dose of study treatment and agree to use effective contraception, during the study and for days following the last dose of study treatment.
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least months after receiving the final treatment of bevacizumab and/or olaparib
Have a negative serum pregnancy test at baseline (within days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Female Subjects of Childbearing Potential: Subjects must have a negative serum pregnancy test within days prior to the first dose of study treatment and agrees to use effective contraception, throughout the treatment period and for months after the last dose of study treatment.
Patients with reproductive potential (for example, females menopausal for less than year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< days prior to treatment initiation
Women of child-bearing potential (WOCBP) must have a negative pregnancy test prior to enrollment and within days of the first administration of study treatment, and must also agree to use effective contraception throughout the treatment period and for months after the last dose of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
Females of childbearing potential (a female not post-menopausal for at least months or not surgically sterilized) must have a negative beta-human chorionic gonadotropin (HCG) pregnancy =< days prior to day of cycle ; if the pregnancy test is outside institutional normal range at pretreatment, the subject must have a second pregnancy test; if the second pregnancy test is outside institutional normal range then a gynecology consult is needed to confirm the subject is not pregnant; all patients must agree to use an effective contraceptive method during the course of the study
Women of childbearing potential must have a negative serum pregnancy test within days before the first dose of study treatment and agree to use effective contraception during the study; NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with dabrafenib.
Patients with reproductive potential (eg, females menopausal for less than year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< days prior to treatment initiation
Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
Women of childbearing potential must have a negative pregnancy test during Screening and must agree to use highly effective physician-approved contraception from Screening to days following the last study drug administration
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception, as defined in protocol, during the study and for days following the last dose of study treatment.
Women of childbearing potential must have a negative serum or urine pregnancy test within days of first dose of study treatment and agree to use effective contraception during the study and for months following the last dose of study treatment
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 weeks ( days) following the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment followed by negative urine or serum pregnancy test once every weeks (prior to next dose cycle) thereafter.- Adequate organ system function as defined in the protocol. Part Inclusion Criteria
Female subjects of childbearing potential must have negative pregnancy test within days prior to first dose of study drug; practicing an acceptable form of birth control for greater than months prior to screening and commits to use for the duration of the study and for months following the last dose of study treatment.
female subject must have a negative serum pregnancy result within days before the start of the study; Both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for months after discontinuation of treatment
If childbearing potential must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization and for at least months following last plerixafor dose; female patients will undergo pregnancy test prior to stem cell mobilization therapy
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (? 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 months after the last dose of study drug.
Females of Childbearing Potential (FCBP) must have a negative pregnancy test within - days and again within hours of starting Cycle and must use an effective double-method contraception for ? days prior to, during, and for ? days after completion of study therapy.
Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through days after last dose of study drug.
Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception; a woman is eligible to enter and participate in the study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who has had a hysterectomy or has had a bilateral oophorectomy (ovariectomy)\r\n* Childbearing potential, has a negative serum pregnancy test during the screening period and agrees to avoid sexual activity or use accepted methods of contraception from screening through follow-up\r\n* Men with a female partner of childbearing potential are eligible to enroll and participate in the study if they have had either a prior vasectomy or agree to avoid sexual activity or use appropriate barrier contraception from screening through post-treatment follow-up
Female subjects with reproductive potential must have a negative serum pregnancy test within days prior to the start of therapy. Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for days (females and males) following the last dose of AG-
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of the pre-study visit, through the course of the study and for days after the last dose of study medication\r\n* Female patients of childbearing potential should have a negative urine or serum pregnancy within hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* Female patients of childbearing potential should be willing to use methods of birth control or be surgically sterile, or abstain from heterosexual activity from the time of the pre-study visit, through the course of the study and for days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > year\r\n* Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and months after completion of MK- administration
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception as defined in the protocol.
Pregnant and lactating women are not eligible; all participants of reproductive age must have a negative serum pregnancy test at baseline and agree to use an effective barrier method of contraception during the entire period of treatment on the study
Female patients of child bearing potential must have a negative pregnancy test (within days from the time of randomization); patients must agree to use effective contraception (both males and females) for weeks prior to the first dose of each study treatment and for weeks after the last dose of each study treatment
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception during the study and for days following the last dose of investigational product.
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception, from days prior to the first dose of study treatment, throughout the study, and for months following the last dose of chemotherapy or weeks after the last dose of GSK, whichever is latest. .
Women of childbearing potential must have a negative serum pregnancy test within days prior to randomization and agree to use effective contraception, during the study, and for days after the last dose of study treatment
If female and has begun menstruating, must have a negative pregnancy test prior to study participation and agree to remain abstinent or use a barrier form of contraception
Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment and agree to use effective contraception during the study and for one year following the last dose of study drug.
Pregnant female or nursing mother. All females with an intact uterus (unless amenorrheic for the months before enrollment) must have a negative serum pregnancy test at screening. All non-sterile or non-postmenopausal females must practice a medically accepted method of contraception over the course of the study and for days after the last dose of study agent.
Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
Women of childbearing potential must have had a negative pregnancy test (urine or serum) ? days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for months after the last dose.
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for weeks following the last dose of study drugs; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Female patients of childbearing potential must have a negative serum pregnancy test at screening and must agree to use a highly effective form of contraception from the time of the first dose of study drug through days after the last dose of study drug.
Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through days after the last dose of study drug.
Female subjects of childbearing potential (FCBP) must have a negative urine or serum pregnancy test AND must agree to use effective contraception throughout the study, starting at the first dose of chemotherapy for at least months thereafter and months after the gene modified cells are no longer detected in the blood, whichever is longer. Or
Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through days after the last dose.
Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for days after the last dose of study drug\r\n* Childbearing potential is defined as girls who are > Tanner stage , except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy\r\n* Urine pregnancy tests are acceptable
If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of months);
Nonpregnant, nonlactating female patients; patients of childbearing potential must implement an effective method of contraception during the study; all women of childbearing potential must have a pre-study negative serum or urine pregnancy test within days prior to study entry
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study
A female subject is eligible to participate if she is of: Non-childbearing potential or women of childbearing potential must have a negative serum pregnancy test within hours of first dose of study treatment and agree to use effective contraception during the study and for days following the last dose of study treatment.
Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than % per year) from the screening visit through days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
Male and female subjects of childbearing potential must agree to use a highly reliable method of birth control (expected failure rate < % per year) from the Screening Visit through days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
Female participants: Are women of child-bearing potential who test negative for pregnancy within 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 weeks following the last dose of the study drug and also must not be breastfeeding, OR are postmenopausal women.