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

• Status: Terminated
• Trial end date: 2020-09-02
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria:

• Men (> 18 years of age) with histologically or cytologically confirmed adenocarcinoma or poorly differentiated adenocarcinoma of the prostate without neuroendocrine differentiation with HRD deficiency by CTC-HRD assay and/or deleterious germline or somatic mutation in BRCA1 or BRCA2; mCRPC measurable disease and/or bone disease. • PSA progression with > 3 rising PSA levels with > 1 week between determinations and a screening PSA > 2 μg/L (2 ng/mL).

• Must be surgically or medically castrated with serum testosterone levels of < 1.73 nmol/L (50 ng/dL), must have received > 1 prior androgen receptor-targeted therapy, and must have received > 1 taxane-based therapy.

• mCRPC with 1 or 2 of the following:

• Measurable disease per RECIST v1.1

• Bone disease

• CTC-HRD+ or BRCA1/2 mutation

• PSA progression (PCWG3 criteria)

• ≥1 androgen receptor-targeted therapy (eg, abiraterone acetate/prednisone or enzalutamide) for mCRPC with progressive disease

• ≥1 taxane for metastatic prostate cancer

• Prior sipuleucel-T and checkpoint inhibitors"

Key Exclusion Criteria:

• Chemotherapy, hormonal therapy, biologic therapy, radionuclide therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies ≤ 5 half-lives if the half-life is known, ≤ 14 days if not known, before start of study treatment

• Continued treatment with a bisphosphonate or denosumab is allowed, if administered at a stable dose > 28 days before start of study treatment

• Radiotherapy ≤ 21 days (≤ 14 days, if single fraction of radiotherapy) before start of study treatment

• Prior treatment for prostate cancer with any of the following:

• poly ADP ribose polymerase (PARP) inhibitor

• Platinum

• Cyclophosphamide

• Mitoxantrone

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.