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 early · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT02326844

Run by

National Cancer Institute (NCI)

People needed

3

Starts

2015-03-02

Expected to finish

2016-04-14

Last updated by the study team

2020-08-18

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had prior BMN 673 (talazoparib) therapy.
• Patients with known brain metastases diagnosed within 1 year will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Exception: patients with brain metastases diagnosed greater than 1 year prior to study entry may be considered if they received sterilizing therapy to the central nervous system (CNS) (resection or radiation) and have been CNS progression-free for the 1-year period.
• Lack of recovery of prior cancer therapy-related adverse events to Grade less than or equal to 1 (National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE) v4.03; except alopecia). Stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the PI. Patients with platinum-related grade 2 or greater hypomagnesemia (on replacement) will be eligible.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, clinically significant gastrointestinal (GI) bleeding or hemoptysis within 28 days prior to the start of the study, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics.
• Another previous or current invasive malignancy within the last 2 years, with the exception of curatively treated stage Ia cervical carcinoma, or resected stage Ia endometrial cancer, and noninvasive nonmelanoma skin cancers.
• Human immunodeficiency virus (HIV)- positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with BMN 673 (talazoparib). HIV- positive patients who are not on combination antiretroviral therapy (cART) and have cluster of differentiation 4 (CD4) counts > 500 are eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BMN 673 (talazoparib)
• Patients who are receiving any other investigational or commercial agents with the intent to treat the malignancy.
• Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption.
• Use of nasogastric or gastric (G)-tube administration.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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