A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

• Status: Completed
• Trial end date: 2021-07-27
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborator: Foundation Medicine
• Treatments: Rucaparib

Criteria

Inclusion Criteria:

• Be 18 years old at the time the informed consent form is signed

• Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate

• Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)

• Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease

• Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

Exclusion Criteria:

• Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer

• Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy

• Symptomatic and/or untreated central nervous system metastases

• Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib