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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Castration-Resistant Prostate Cancer (mCRPC) HRD | Drug: Pamiparib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | February 14, 2019 |
Actual Primary Completion Date : | August 6, 2020 |
Actual Study Completion Date : | August 6, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Pamiparib
Participants will receive pamiparib for a period up to 1 year
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Drug: Pamiparib
60 mg orally twice daily (BID)
Other Name: BGB-290 |
- 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 ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712930
United States, Georgia | |
University Cancer and Blood Center | |
Athens, Georgia, United States, 30607 | |
United States, New York | |
Montefiore Einstein Cancer Center | |
Bronx, New York, United States, 10461 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 | |
Australia, New South Wales | |
Gosford Hospital | |
Gosford, New South Wales, Australia, 2250 | |
Liverpool Hospital | |
Liverpool, New South Wales, Australia, 2170 | |
Calvary Mater Newcastle | |
Waratah, New South Wales, Australia, 2298 | |
Australia, Queensland | |
Icon Cancer Care Foundation | |
South Brisbane, Queensland, Australia, 044101 | |
Puerto Rico | |
Pan American Oncology Trials, LLC | |
Rio Piedras, Puerto Rico, 935 | |
Spain | |
L Hospitalet de Llobregat | |
Barcelona, Spain, 8035 |
Principal Investigator: | Simon Chowdhury, MD | Guy's and St Thomas' NHS Foundation Trust |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT03712930 |
Other Study ID Numbers: |
BGB-290-202 2018-002587-28 ( EudraCT Number ) |
First Posted: | October 19, 2018 Key Record Dates |
Last Update Posted: | September 23, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |