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
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
Drug | Synonyms | Arms |
---|
Pamiparib | BGB-290 | Pamiparib |
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
Name | Type | Description | Interventions |
---|
Pamiparib | Experimental | Participants will receive pamiparib for a period up to 1 year | |
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