Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency
Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC); Homologous Recombination Deficiency (HRD)
MeSH terms: Prostatic Neoplasms
Intervention: Pamiparib
Intervention description: 60 mg orally twice daily (BID)
Intervention MeSH terms: Pamiparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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

        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.