Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Inclusion\n\n . Has provided written informed consent\n\n . Has advanced solid tumors (excluding breast cancer)\n\n . Has normal renal function, mild, moderate, or severe renal impairment and is not on\n dialysis\n\n . ECOG performance status of ?\n\n . Is able to take medications orally\n\n . Has adequate organ function\n\n . 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 . Certain serious illnesses or medical condition(s)\n\n . 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 . Has received TAS-\n\n . Has unresolved toxicity of greater than or equal to CTCAE Grade attributed to any\n prior therapies\n\n . Is a pregnant or lactating female
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of childbearing potential must agree to use adequate contraceptive measures until months after the last study drug is taken. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least months following the last dose of poly-ICLC. Women of childbearing potential must have a negative pregnancy test. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
Females of childbearing potential (FCBP) must have a negative serum pregnancy test and agree to use appropriate methods of birth control
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; female patients of child-bearing potential must have negative pregnancy test
ARM I&II: Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of child-bearing potential (women who are not free from menses for > years, post-hysterectomy/oophorectomy, or surgically sterilized) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to days after the completion of adjuvant therapy
Negative pregnancy test done =< days prior to registration, for women of childbearing potential only; Note: patients must agree to adequate birth control during the study and for up to months after discontinuation of study medication
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
Patients of childbearing potential must agree to use adequate birth control during and for months after participation in this study
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within hours prior to receiving the investigational product
Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study
Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to months after the last intake of ODM-.
Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for months after the last dose) if conception is possible during this interval.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within hours prior to receiving the investigational product
Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment; females must agree to adequate birth control if conception is possible during the study
Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for months after study completion
Agree to use adequate birth control, if of childbearing potential
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to months after discontinuation of study drug treatment
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within hours prior to receiving the investigational product; a positive pregnancy test will prohibit the subject from receiving the investigational product
Women of childl-bearing potential must have a negative pregnancy test within days prior to starting the study drug. Beth males and females must agree to adequate birth control if conception is possible during the study and for months after the last dose
Willingness to use acceptable birth control. Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female subjects of child-bearing potential must have a negative pregnancy test.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus
Women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
Inclusion\n\n . Has provided written informed consent\n\n . Has advanced solid tumors (excluding breast cancer)\n\n . Has normal hepatic function, mild, moderate, or severe hepatic impairment\n\n . ECOG performance status of ?\n\n . Is able to take medications orally\n\n . Has adequate organ function\n\n . 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 . Certain serious illnesses or medical condition(s)\n\n . 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 . Has received TAS-\n\n . Has unresolved toxicity of greater than or equal to CTCAE Grade attributed to any\n prior therapies\n\n . Is a pregnant or lactating female
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.