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

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.

Timeline

Start

2015-03-02

Primary completion

2016-04-14

Completion

2016-04-14

Publications

• Background Lee JM, Hays JL, Annunziata CM, Noonan AM, Minasian L, Zujewski JA, Yu M, Gordon N, Ji J, Sissung TM, Figg WD, Azad N, Wood BJ, Doroshow J, Kohn EC. Phase I/Ib study of olaparib and carboplatin in BRCA1 or BRCA2 mutation-associated breast or ovarian cancer with biomarker analyses. J Natl Cancer Inst. 2014 May 19;106(6):dju089. doi: 10.1093/jnci/dju089. Print 2014 Jun.
• Background O'Sullivan CC, Moon DH, Kohn EC, Lee JM. Beyond Breast and Ovarian Cancers: PARP Inhibitors for BRCA Mutation-Associated and BRCA-Like Solid Tumors. Front Oncol. 2014 Feb 28;4:42. doi: 10.3389/fonc.2014.00042. eCollection 2014.
• Background Lee JM, Ledermann JA, Kohn EC. PARP Inhibitors for BRCA1/2 mutation-associated and BRCA-like malignancies. Ann Oncol. 2014 Jan;25(1):32-40. doi: 10.1093/annonc/mdt384. Epub 2013 Nov 12.

Drugs

Indications