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

NCT03712930 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: BGB-290-2022018-002587-28
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 9

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

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC); Homologous Recombination Deficiency (HRD)

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) Determined by Independent Review Committee

  ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC).

  Up to 1 year and 6 months

• Prostate-Specific Antigen (PSA) Response Rate

  PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline \[confirmed by a second PSA value ≥ 3 weeks later\] for CTC-HRD-positive participants with or without measurable disease.

  Up to 1 year and 6 months

Secondary Outcomes (11)

• Duration of Response (DOR) by IRC

  Up to 1 year and 7 months

• Objective Response Rate by Investigator

  Up to 1 year and 6 months

• Time to Objective Response by Investigator

  Up to 1 year and 6 months

• Clinical Benefit Rate By Investigator

  Up to 1 year and 6 months

• Time to PSA Response

  Up to 1 year and 6 months

Study Arms (1)

Pamiparib

EXPERIMENTAL

Participants will receive pamiparib for a period up to 1 year

Drug: Pamiparib

Interventions

Pamiparib DRUG

60 mg orally twice daily (BID)

Also known as: BGB-290

Pamiparib

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (9)

University Cancer and Blood Center

Athens, Georgia, 30607, United States

Location

Montefiore Einstein Cancer Center

The Bronx, New York, 10461, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Icon Cancer Care Foundation

South Brisbane, Queensland, 044101, Australia

Location

Pan American Oncology Trials, LLC

Rio Piedras, 935, Puerto Rico

Location

L Hospitalet de Llobregat

Barcelona, 8035, Spain

Location

MeSH Terms

Interventions

pamiparib

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 19, 2018
• Study Start: February 5, 2019
• Primary Completion: August 6, 2020
• Study Completion: September 2, 2020
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (3); AU (4); ES (1)