Willing to perform at least two methods of contraception
Willing to use contraception throughout the study period.
If female, is not pregnant or breastfeeding, and agrees to use contraception during the treatment period and for ?120 days after last dose of study treatment.
Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate during and for 6 months after completion of study therapy (see Section 4.5.3).
Fertile men must also agree to use adequate contraception (2 barrier methods or abstinence) during the study and for up to 4 months after the last dose of study drug
Male patients: Willing to use adequate contraception (barrier or abstinence) while on treatment with study drug and for 3 months after finishing treatment
Female patients: Willing to use adequate contraception (barrier or abstinence) while on treatment with study drug and for 3 months after finishing treatment
Subjects must agree to use adequate contraception (i.e. barrier method) for the duration of study participation, and for three months after discontinuing therapy
Willing to use adequate contraception for the duration of time on the study and for 6 months after the last therapy
Pregnancy or breastfeeding; patients of childbearing capability should agree to use contraception
Patients who are not pregnant; committed to using adequate contraception through week 15 if of childbearing age; condom use will be encouraged
Patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for three months after discontinuing therapy
Fertile males not willing to use contraception
Appropriate contraception in both genders
For both male and female subjects, willingness to use adequate contraception.
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment
Males must agree to use an acceptable form of contraception per institutional practices
Patient must be willing to practice two forms of contraception, one of which must be a barrier method, from study entry until at least 35 days after study treatment. Patients surgically sterilized or who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) do not require contraception.
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in the Duke Contraception Policy
For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception; for men: agreement to use a barrier method of contraception during the treatment period
Participants must agree to use appropriate contraception.
Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices
Willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation
Men who are unwilling to employ adequate contraception measures during the study and for 30 days after the final dose of study therapy
Refusal to use adequate contraception for fertile patients (females and males)
Fertile males not willing to use contraception, as stated above
Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or LDAC
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
Male subject agrees to use an acceptable method of contraception for the duration of the study
All patients must use adequate contraception during participation in this trial and for 3 months following completing therapy
Men participate in the study must be surgically sterile or must agree to use adequate contraception prior to study entry and for the duration of study participation and after for a certain amount of time (as defined below); the investigator shall review contraception methods and the time period that contraception must be followed; the duration of mandatory contraception is based on clearance of the investigational drug (5 half-lives after treatment completion); for males, an additional 90 days is required to complete turnover of drug-exposed sperm; calculation of duration of mandatory contraception: the half-life of cisplatin is 20-30 minutes, half-life of methotrexate is 8-15 hours and half-life of gemcitabine is 42-94 minutes; thus, contraception for men is required for up to 14 weeks after the last treatment
Willing to use contraception when appropriate
Male patients must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception during the study and for 90 days after dosing.
Male participants must be willing to use an adequate method of contraception
Male patients must agree to use an adequate method of contraception for the duration of the study
Male subject agrees to use an acceptable method of contraception for the duration of the study
Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate during and for 6 months after completion of study therapy.
Adequate contraception is defined as hormonal birth control, intrauterine device, barrier method or total abstinence; patients who are unable or unwilling to use adequate contraception are NOT eligible
7. Participants must agree to use an adequate method contraception.
ARM A: The patient and their partner agree to use a barrier method of contraception during the study and 4 months following end of active treatment
ARM B: The patient and their partner agree to use a barrier method of contraception during the study and 4 months following end of active treatment
The patient must be willing to comply with fertility requirements as below:\r\n* Male patients must agree to use an adequate method of contraception for the duration of the study and for 28 days afterwards\r\n* Female patients must be either postmenopausal, free from menses >= 2 yrs, surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening (4 weeks prior to initiating treatment) and for 28 days after treatment, per POMALYST REMS program\r\n* Patients must agree not to donate blood, sperm/ova during the course of taking protocol therapy and for at least 4 weeks after stopping treatment
Refusal to use adequate contraception for fertile patients (females and males) while\n             on treatment and for 12 weeks after the last dose of rociletinib
Patients must agree to use 2 methods of adequate contraception for the duration of study participation, and for four months after discontinuing therapy
Patients must agree to use dual forms of contraception from the time of consent until 6 months after completion of the study
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study (and for up to 12 weeks after the last dose of study drug) to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Male patient agrees to use an adequate method of contraception for the duration of the study
Women who are pregnant or lactating or refuse to commit to use contraception anytime during the study
Male patient agrees to use an adequate method of contraception
Female subjects in child bearing age must be using acceptable contraception methods such as hormonal contraception or two forms of barrier contraception. Acceptable contraception must be used consistently from 30 days before screening until 3 years following surgery Exclusion Criteria: Pre-operative exclusion criteria:
If female, is post-menopausal, surgically sterilized or willing to use an effective method of contraception for the duration of the study and for 3 months after the end of treatment. If male, has agreed to use barrier method for contraception for the duration of the study and for 3 months after the end of treatment.
Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion, will not be eligible to participate in the study
Contraception.
commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
Agree to use contraception per protocol
WOCBP and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care
Male subject agrees to use an acceptable method for contraception for the duration of the study
Patients who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization
Fertile males or females of childbearing potential agree to use adequate contraception prior to study entry
Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy
Females must be surgically or biologically sterile or postmenopausal or, if of childbearing potential, must agree to use an adequate method of contraception during the study until 30 days after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment
Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study.
Willing to use double-barrier contraception if sexually active and not surgically sterilized (female only)
Willingness to use a medically acceptable method of contraception throughout the study period and for 4 weeks after the final administration of AZD1775 or longer if needed as per chemotherapies‘ product information (all subjects)
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Use of adequate contraception (as described in protocol)
Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of PBI 05204, as follows:
Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of lenalidomide
Men must be willing to use appropriate contraception throughout study and for 6 months after; women must be willing to use appropriate contraception throughout study and for 20 months after
Sexually active patients must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 3 months after the last dose of BMN 673
Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
Females must be surgically or biologically sterile or postmenopausal or if of childbearing potential, must agree to use an adequate method of contraception during the study until 30 days after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Males are eligible to enter and participate in the study if they have either had a prior vasectomy or agree to avoid sexual activity or use adequate contraception from screening through two months post the last dose of decitabine
Because of the unknown potential risk to a gamete and/or developing embryo from these investigational therapies, patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for three months after discontinuing therapy.
Patients must agree to practice adequate contraception.
Patients who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization
Male subject agrees to use an acceptable method for contraception for the duration of the study
Male subject agrees to use an acceptable method for contraception for the duration of the study
Male subject agrees to use an acceptable method for contraception for the duration of the study.
Female of childbearing potential must be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation), abstinent (at the discretion of the investigator), or agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 2 years. - Males must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) at the discretion of the investigator.
Male patients agree to use an adequate method of contraception for the duration of the study
Male patients agree to use an adequate method of contraception for the duration of the study
Male subject agrees to use an acceptable method for contraception for the duration of the study
Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion
Patients must be willing and able to comply with the FDA mandated iPLEDGE program for treatment with isotretinoin (cRA). Patients must sign specific informed consents for treatment with cRA, as mandated by iPLEDGE guidelines. Women of childbearing potential must not be pregnant, must not be breast-feeding and must practice adequate contraception during and one month after participation in the study. Male and Female patients on treatment with vorinostat must agree to use an adequate method of contraception for the duration of the study, and for 30 days after the last dose of study medication.
Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib and 2 weeks after the last dose of erlotinib
Females of childbearing potential with a fertile male sexual partner must agree to employ adequate contraception for the duration of the study.
If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator
If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator
Sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study
Male patients must agree to use an adequate method of contraception.
Agree to use adequate contraception
Agree to use contraception
Subjects of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of crenolanib
Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 16 weeks after the last dose of study treatment
Patients unwilling to use adequate contraception
Agree to use contraception
Females must be surgically sterile, one year post menopausal or negative results for a pregnancy test performed at Screening and agree to use two methods of contraception; Males who have not had a vasectomy must agree to two methods of contraception
Is the subject willing to use condoms for contraception for 6 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer. If the subject is a fertile female, is she willing to use contraception for at least 12 months?
Agree to use adequate contraception
Male subject agrees to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Fertile males not willing to use contraception, as stated above
For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
Patients must be postmenopausal, free from menses for > 1 year, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through180 days after the last dose of study treatment.
Male subject agrees to use an acceptable method for contraception for the duration of the study
Male subject agrees to use an acceptable method of contraception for the duration of the study
Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant while on study drug and for 3 months after discontinuation from study drug, and must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc), barrier method contraception (i.e. condoms), or abstinence during that time frame
Men engaging in sexual intercourse with a FCBP must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc), barrier method contraception (i.e. condoms), or abstinence while on study drug and for 3 months after discontinuation from study drug
Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication
Agree to contraception requirements.
Pregnant and lactating females, and unwillingness to use contraception; or male subject not willing to use contraception during and for 21 days after the last dose of pazopanib therapy
Fertile patients must use adequate contraception
Patients unwilling to use contraception
Willing to use adequate contraception to avoid pregnancy or impregnation until 2 weeks after discontinuing study agent
Willingness to use adequate contraception to avoid pregnancy or impregnation until 2 weeks after discontinuing study agent
Pregnant, unwilling to use adequate contraception during study treatment duration, had given birth, or nursed at any time during the last 12 months\r\n* All heterosexually active women who may become pregnant must agree to use a reliable nonhormonal contraceptive method during the study and for 2 months after completing study medications; reliable nonhormonal methods of contraception include barrier contraception and an intra-uterine device (IUD); [Note: Women who had tubal ligation or had a partner who had undergone a vasectomy (and are monogamous) are eligible for the study and are not required to use barrier contraception
For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception; for men: agreement to use a barrier method of contraception during the treatment period
Subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy
Using an adequate method of contraception for at least 3 months with no changes and will remain on the contraception for the duration of the trial; an adequate method of contraception is defined as either a hormonal based method (except vaginal rings); an intrauterine device (IUD) (inserted at least 30 days prior to enrollment); female sterilization; or sexual activity with a partner who had a vasectomy
Willing to continue on the same or similar type of contraception during the 12 month course of study; if using non-hormonal contraception, continue that and if hormonal contraception continue that; if heterosexually active, must be agreeable to use some form of contraception during the trial unless husband or partner has had a vasectomy or subject has had uterus removed; safety of SDG during pregnancy has not been documented
Use of adequate contraception during the study
has practiced adequate contraception for 30 days prior to vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
has practiced adequate contraception for 30 days prior to vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Willingness to use adequate contraception for 12 months after completion of all therapy
Willingness to use adequate contraception for 12 months after completion of all therapy
Agrees to use an adequate method of contraception during the study and until 3 months after the last treatment.
TREATMENT GROUP: Willing to avoid oral contraception use (which is not recommended while on tamoxifen treatment) for the duration of the study participation
Willing to abstain from procreative sex or partake in appropriate form of contraception; for the purpose of this study, condom use or abstinence will be required
Willing to use adequate contraception if applicable, and to continue use for 16 weeks post last dose of GSK1120212
Patient must be a candidate for systemic therapy with erlotinib based on clinical assessment; patients must meet the following criteria before beginning therapy (Note: these are not required for initial study enrollment and plasma genotyping):\r\n* ECOG performance status of 0-2\r\n* Platelets > 75\r\n* Aspartate aminotransferase (AST) & alanine aminotransferase (ALT) < 3 x the upper limit of normal\r\n* Creatinine clearance > 30 mL/min by Cockroft-Gault\r\n* No other contraindication to erlotinib\r\n* Female participants of child-bearing age must agree to use adequate contraception (hormonal, barrier or abstinence) for the duration of the study while receiving erlotinib and undergo a pregnancy test; any evidence or suspicion of pregnancy should be reported to the treating physician immediately\r\n* Male participants must agree to use adequate contraception for the duration of the study while receiving erlotinib