Clinical Trials /

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

NCT03712930

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Treatment of 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
  • SECONDARY ID: 2018-002587-28
  • NCT ID: NCT03712930

Conditions

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • HRD

Interventions

DrugSynonymsArms
PamiparibBGB-290Pamiparib

Purpose

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

Detailed Description

      This is a global, Phase 2, open-label study of pamiparib in approximately 100 participants
      with with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating
      tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). Participants in Cohort
      1 will include 50 mCRPC participants 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 participants with bone
      metastasis only and positive or negative/unknown BRCA1/2. Cohort 3 and 4 will include 20
      mCRPC CTC-HRD negative/unknown participants with BRCA1/2 positive mutations, metastatic
      disease (measurable soft tissue with/without bone), and bone only. Participants 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
PamiparibExperimentalParticipants will receive pamiparib for a period up to 1 year
  • Pamiparib

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

          -  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.
      
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:Up to study completion, an average of 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response
Time Frame:Up to study completion, an average of 1 year
Safety Issue:
Description:
Measure:Objective Response Rate by Investigator
Time Frame:Up to study completion, an average of 1 year
Safety Issue:
Description:
Measure:Time to Objective Response
Time Frame:Up to study completion, an average of 1 year
Safety Issue:
Description:
Measure:Clinical benefit rate
Time Frame:Up to study completion, an average of 1 year
Safety Issue:
Description:Proportion of participants with a documented confirmed complete response (CR), partial response (PR), or stable disease

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:BeiGene

Last Updated

June 2, 2021