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 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
Drug | Synonyms | Arms |
---|
Pamiparib 60 mg PO BID | pamiparib | Approximately 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
Name | Type | Description | Interventions |
---|
Approximately 100 subjects to receive pamiparib orally. | Experimental | | |
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 |
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