Open-Label Extension and Safety Study of Talazoparib

Completed · Phase 2

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT02921919

Run by

Pfizer

People needed

120

Starts

2016-11-08

Expected to finish

2021-07-20

Last updated by the study team

2022-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States
• CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• UCLA Hematology/Oncology - Burbank — Burbank, California, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• UCLA Hematology/Oncology - Pasadena — Pasadena, California, United States
• UCLA Hematology/Oncology - Porter Ranch — Porter Ranch, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• UCLA Torrance Oncology — Torrance, California, United States
• UCLA Hematology/Oncology - Santa Clarita — Valencia, California, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Memorial Hospital West — Pembroke Pines, Florida, United States
• IU Health Bloomington Hospital — Bloomington, Indiana, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Investigational Drug Senvices — Indianapolis, Indiana, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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