- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- 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 45 days after the last
dose.
- Male patients must use a condom when having sex with a pregnant woman or with a woman
of childbearing potential from the time of the first dose of talazoparib through 105
days after the last dose. Contraception should be considered for a nonpregnant female
partner of childbearing potential.
- Female patients may not be breastfeeding at the first dose of talazoparib and must not
breastfeed during study participation through 45 days after the last dose of
talazoparib.
- Permanently discontinued from any Medivation sponsored study with talazoparib alone or
in combination with another agent.
- Received an antineoplastic therapy or investigational agent after treatment with
talazoparib in the originating protocol.
- Has a clinically significant cardiovascular, dermatologic, endocrine,
gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or
pulmonary disorder or any other condition, including excessive alcohol or drug abuse,
or secondary malignancy, that may interfere with study participation in the opinion of
the investigator.
- Diagnosis of myelodysplastic syndrome (MDS).