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
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

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