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A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Not Recruiting
Trial ID: NCT02952534
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.
Official Title
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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
Intervention(s):
drug: Rucaparib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Carleen Tabari
650-725-9180