A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Purpose
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.
Condition
- Metastatic Castration Resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rucaparib |
Oral rucaparib (monotherapy) |
|
More Details
- Status
- Completed
- Sponsor
- pharmaand GmbH