Clinical Trials /

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

NCT03712930

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency
  • Official Title: A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)

Clinical Trial IDs

  • ORG STUDY ID: BGB-290-202
  • NCT ID: NCT03712930

Conditions

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)

Interventions

DrugSynonymsArms
Pamiparib 60 mg PO BIDpamiparibApproximately 100 subjects to receive pamiparib orally.

Purpose

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Approximately 100 subjects to receive pamiparib orally.Experimental
  • Pamiparib 60 mg PO BID

Eligibility Criteria

        Inclusion Criteria:

          -  "The population under study is 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. Patients must have PSA progression with > 3 rising PSA
             levels with > 1 week between determinations and a screening PSA > 2 μg/L (2 ng/mL).
             Patients 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"

        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:

                    -  PARP inhibitor

                    -  Platinum

                    -  Cyclophosphamide

                    -  Mitoxantrone"
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate determined by independent central review
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:
Measure:Objective Response Rate by Investigator
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:
Measure:Time to Objective Response
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:BeiGene

Last Updated