Last updated on June 2019

Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency


Brief description of study

This study is designed to evaluate the efficacy of pamiparib in patients with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All patients will receive pamiparib. The purpose of this study is to demonstrate that pamiparib will improve Objective Response Rate (ORR) and Prostate-Specific Antigen (PSA) response rate

Detailed Study Description

"This is a global, Phase 2, open-label study of pamiparib in approximately 100 patients with with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). Subjects in Cohort 1 will include 50 mCRPC patients with CTC-HRD-positive, measurable metastatic disease (soft tissue with/without bone lesions), and positive BRCA1/2 mutation or negative/unknown BRCA1/2 mutation. Cohort 2 will include 30 mCRPC CTC-HRD positive patients with bone metastasis only and positive or negative/unknown BRCA1/2. Cohort 3 and 4 will include 20 mCRPC CTC-HRD negative/unknown patients with BRCA1/2 positive mutations, metastatic disease (measurable soft tissue with/without bone), and bone only. Subjects will undergo PSA level assessments approximately every 4 weeks as well as tumor assessments every 8 weeks, or as clinically indicated. Administration of pamiparib will continue until disease progression, unacceptable toxicity, death or another discontinuation criterion is met."

Clinical Study Identifier: NCT03712930

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Pan American Oncology Trials, LLC

Rio Piedras, Puerto Rico
1.12miles
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Recruitment Status: Open


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