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

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ClinicalTrials.gov Identifier: NCT03712930
Recruitment Status : Terminated (Sponsor's decision to revisit the development approach for prostate cancer.)
First Posted : October 19, 2018
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE February 14, 2019
Actual Primary Completion Date August 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • Objective Response Rate determined by independent central review [ Time Frame: Up to study completion, an average of 1 year ]
  • Prostate-Specific Antigen (PSA) response rate [ Time Frame: Up to study completion, an average of 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Objective Response Rate determined by independent central review [ Time Frame: through study completion, an average of 1 year ]
  • Prostate-Specific Antigen (PSA) response rate [ Time Frame: through study completion, an average of 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • Duration of response [ Time Frame: Up to study completion, an average of 1 year ]
  • Objective Response Rate by Investigator [ Time Frame: Up to study completion, an average of 1 year ]
  • Time to Objective Response [ Time Frame: Up to study completion, an average of 1 year ]
  • Clinical benefit rate [ Time Frame: Up to study completion, an average of 1 year ]
    Proportion of participants with a documented confirmed complete response (CR), partial response (PR), or stable disease
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Duration of response [ Time Frame: through study completion, an average of 1 year ]
  • Objective Response Rate by Investigator [ Time Frame: through study completion, an average of 1 year ]
  • Time to Objective Response [ Time Frame: through study completion, an average of 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency
Official Title  ICMJE 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)
Brief 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • HRD
Intervention  ICMJE Drug: Pamiparib
60 mg orally twice daily (BID)
Other Name: BGB-290
Study Arms  ICMJE Experimental: Pamiparib
Participants will receive pamiparib for a period up to 1 year
Intervention: Drug: Pamiparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 1, 2020)
13
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
100
Actual Study Completion Date  ICMJE August 6, 2020
Actual Primary Completion Date August 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03712930
Other Study ID Numbers  ICMJE BGB-290-202
2018-002587-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Chowdhury, MD Guy's and St Thomas' NHS Foundation Trust
PRS Account BeiGene
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP