Pregnancy or lactation or unwillingness to use adequate method of birth control.
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal renal function, mild, moderate, or severe renal impairment and is not on\n             dialysis\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, within the specified time\n             frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
If fertile, willing to use effective birth control methods during the study
Highly effective forms of birth control include:
Highly effective forms of birth control include:
Patient on reliable birth control: combined oral contraceptive pill (OCP), long acting reversible contraceptive program (LARCP), bilateral tubal ligation (BLT) and Depo Provera shot/birth control shot
Patient not on reliable birth control
Willingness to use 2 methods of birth control during the study and for 12 months after the last dose of ZW25
Patients of reproductive potential must use an acceptable form of birth control or abstain from sexual activity
Female of childbearing potential, unless birth control used on study and 12 wks post-treatment.
Male patients must agree to use adequate birth control during the study and up to 30 days after the last avelumab dose
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
Not willing to use an effective method of birth control
Inability to comply with study procedures or willingness to use adequate birth control
Willing to follow strict birth control measures
Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device (refer to Section 7.3 Permissible and Prohibited Medications/Treatments)
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.
Men who could potentially father a child must also use birth control
All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
Using corticosteroids or estrogen-based oral birth control
Women of childbearing potential (WOCBP) who are pregnant or lactating or unwilling to use 2 forms of effective birth control
Effective birth control should be utilized as indicated
Males must agree to use a medically acceptable form of birth control in order to be in this study and for 3 months after infusion
Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation
Women who are able to become pregnant and men who can father a child must use birth control while on study and for at least 8 weeks after your last dose of study drug(s); acceptable birth control includes a condom or a diaphragm with spermicidal jelly; and birth control methods that are taken by mouth, injected, or implanted; if you are already using birth control, you must check with the study staff to make sure that it is considered one of the acceptable forms to use in this study
Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent\r\n* Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence [no sexual intercourse] or surgical sterilization)
Be non-fertile or not pregnant or lactating & agree to use birth control during the study through the end of last treatment visit
No patients who are pregnant or lactating will be allowed; patients of childbearing potential must practice an effective method of birth control while participating on this study
Patients who do not agree to practice appropriate birth control methods while on therapy.
Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
Females must not be pregnant or breast feeding, and must use accepted birth control methods; males must use accepted birth control methods
Females of childbearing age must be on an acceptable form of birth control per institutional standards
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Subjects are required to agree to practice effective birth control (i.e. abstinence, intrauterine device for female subjects) during the study period.
218 Males and females of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study through 110 days (females) and 170 days (males) after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (males) in combination with hormonal birth control or intrauterine device (IUD) (females).
All patients must practice a highly effective method of birth control
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Male patients must agree to use adequate birth control during the study and up to 6 months after discontinuation of study drug treatment
Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination
Adequate birth control
Adequate birth control in sexually active women of childbearing potential
Pregnancy or nursing or unwilling to take adequate birth control during therapy; NOTE: breastfeeding should be discontinued
Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 6 months after the last vaccination therapy
Patients must not be pregnant, lactating, or unwilling to use birth control
Females of childbearing potential and males not using adequate birth control.
Patients must be able to rinse and expectorate study medication rather than swallow it; female patients must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP
Pregnancy or nursing or unwilling to take adequate birth control during therapy
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
Agree to use a reliable medically approved method of birth control.
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Patients with childbearing potential must agree to use appropriate forms of birth control
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 90 days after the last dose of study treatment; acceptable methods of birth control include condoms with birth control foam, birth control pills, implantable or injectable birth control, birth control patch, intrauterine device (IUD), or diaphragm with spermicidal gel; male patients must use an effective barrier method of contraception (i.e. , condoms with birth control foam or diaphragm with spermicidal gel) during the study and for 90 days following the last dose of study treatment if sexually active with a female of childbearing potential; contraception must be in place at least 2 weeks prior to initiating study treatment; a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Willing to employ adequate and appropriate birth control if applicable\r\n* NOTE: This study is for patients aged 60 and older and most female patients will have entered menopause by this time; however patients should not become pregnant while on this study; pre-menopausal women need to use birth control while on this study and women should not breastfeed a baby while on this study; any man treated on this study will also need to use contraception if his partner is a premenopausal female; patients should check with their health care provider about what kind of birth control methods to use and how long to use them
Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
Two acceptable forms of birth control include:
Willingness to use birth control while on study
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
Patients of both gender must practice a barrier method of birth control while participating in this trial
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control for the duration of the study.
Woman of potential childbearing age agrees to a medically effective birth control method,
Highly effective forms of birth control include:
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control
The patient is pregnant or unwilling to practice appropriate birth control
Adequate birth control in fertile patients
Adequate birth control when appropriate
Any risk of pregnancy - ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or menopause
Not pregnant, not lactating, and agree to use effective birth control
FCBP must agree to use a highly-effective form of birth control while taking the study drug and for 1 month after the last dose of study drug; highly-effective forms of birth control include implants, injectables, birth control pills with 2 hormones, some intrauterine devices (IUDs), or having a sterilized partner; the type of birth control used must be discussed with and approved by the attending physician prior to initiation of study drug
Willing to use physician approved birth control method
Patients who are known or thought to be sexually active must use effective birth control.**
Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.
if heterosexually active must use two forms of birth control
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal hepatic function, mild, moderate, or severe hepatic impairment\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, shunt in the liver within\n             the specified time frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
Adequate birth control methods for the duration of the study
Unwillingness to practice birth control
Highly effective methods of birth control for females & males
Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables ( i.e. depo-provera)
Adequate birth control
Use of acceptable birth control
Female patients of childbearing age not on effective birth control
Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.
Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, intrauterine device [IUD]) or currently pregnant
Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period
Patients must agree to use an effective birth control method
For sexually active females, patient agrees to use acceptable method of birth control
Acceptable birth control.
Participant must be willing to use two effective forms of birth control during protocol therapy; men and women must continue using two effective forms of birth control for 6 months following treatment
Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
If currently menstruating, subjects must use a reliable method of birth control
Pregnant, or had given birth, or nursed at any time during the last 12 months
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
Male patients must agree to use an acceptable form of birth control from study day 1 through at least 90 days after the final dose
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
Must agree to use effective consistent contraception. Hormone-based birth control (pills, patches, or shots) is allowed. Hormone replacement therapy is not allowed for postmenopausal participants.
CONTROL GROUP
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study.
Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
Not currently on estrogen medication for birth control, menopause, or other reason
Willingness to use birth control while on study
CONTROL GROUP
Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
Women of childbearing potential not practicing adequate forms of birth control
Adequate birth control
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.