Overview

BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment

Status:
Terminated

Trial end date:
2016-04-14

Target enrollment:

Participant gender:

Summary

Background: - The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works on tumor cell deoxyribonucleic acid (DNA) damage repair process. Researchers want to see if BMN 673 shrinks cancer again in women with ovarian cancer and whose cancer initially got shrunk but grew back on the first PARP inhibitor. Objective: - To study BMN 673 (talazoparib) in people with ovarian cancer born with a breast cancer (BRCA) mutation and whose cancer got shrunk but became worse after they took a similar drug. Eligibility: - Women at least 18 years old: - with recurrent and/or metastatic germline breast cancer mutation (gBRCAm)-associated ovarian cancer AND - whose disease is growing after already being treated with PARP inhibitors AND - with no other treatment(s) in between the first PARP inhibitors and a screening visit. Design: - Participants will be screened with medical history, physical exam, and heart and blood tests. - Participants will take the study drug by mouth once daily. They will take the drug in 28-day cycles. - They will keep a diary of doses and any side effects. - Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may include: - Blood tests - Physical exam - Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will lie in a machine that takes pictures of their body. - Ultrasound - Participants will have a biopsy before starting the study drug. A small piece of tumor tissue will be removed by needle, guided by a scan. They may have two more biopsies later. - Participants will be followed for 30 days after taking the last dose of study drug. A physical exam, blood tests, and CT or other scans will be done. - Participants will have follow-up calls to ask about any side effects.

Phase:

Phase 2

Details

Lead Sponsor:

National Cancer Institute (NCI)

Treatments:

Poly(ADP-ribose) Polymerase Inhibitors
Talazoparib