TerminatedPhase 2

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

Stopped: Study was closed by the Cancer Therapy Evaluation Program (CTEP)

United States3 participantsStarted 2015-03-02

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Recurrent, and/or metastatic germline breast cancer (BRCA) 1/2 mutation-associated ovarian cancer, with progression on a poly (ADP-ribose) polymerase (PARP) inhibitor monotherapy after attaining a response to that PARPi (complete response (CR), partial response (PR), or stable disease (SD) greater than or equal to 4mo) * Progression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapy. * Patients must be at least 4 weeks from the last dose of prior PARP inhibitor. * All patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory baseline biopsy. It is preferred that this lesion be a lesion that progressed or arose while on the prior PARP therapy. * Histopathologic diagnosis of ovarian cancer (including primary peritoneal and fallopian tube cancers) must be confirmed in the Laboratory of Pathology, National Cancer Institute (NCI). * Age greater than or equal to18 years. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%. * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count greater than or equal to 1,500/mcL * platelets greater than or equal to100,000/mcL * total bilirubin less than or equal to 1.5X upper limit of normal, unless known Gilberts syndrome * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic …

What they're measuring

Objective Response (Complete Response (CR) + Partial Response (PR))

Timeframe: Every 2 cycles, an average of 64 days

Trial details

NCT IDNCT02326844

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2016-04-14

Results submitted2017-01-12