Open-Label Extension and Safety Study of Talazoparib
Trial Status: Enrolling by Invitation
This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.
- 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).
Translational Research In Oncology - US Inc
UCLA / Jonsson Comprehensive Cancer Center
Indiana University / Melvin and Bren Simon Cancer Center
Contact: Erin k Conder
University of Michigan Comprehensive Cancer Center
Wayne State University / Karmanos Cancer Institute
Siteman Cancer Center at Washington University
Rutgers Cancer Institute of New Jersey
M D Anderson Cancer Center
Trial Phase Phase II
Trial Type Treatment
- Primary ID MDV3800-13
- Secondary IDs NCI-2017-00041, 2016-001972-31, C3441010
- Clinicaltrials.gov ID NCT02921919