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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:November 2016
End Date:April 2020
Contact:Clovis Oncology Clinical Trial Navigation Service
Email:clovistrials@emergingmed.com
Phone:1-855-262-3040 (USA)

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TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

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.


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
We found this trial at
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