Open-Label Extension and Safety Study of Talazoparib

Status: Active

Description

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Locations & Contacts

California

Los Angeles
Translational Oncology Research International
Status: Active
Name Not Available
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Pfizer

Trial IDs

Primary ID MDV3800-13
Secondary IDs NCI-2017-00041, 2016-001972-31, C3441010
Clinicaltrials.gov ID NCT02921919