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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.

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).

California

Los Angeles
Translational Research In Oncology - US Inc
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Erin k Conder
Phone: 317-278-4315

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Pfizer

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