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) |
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.
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
46
sites
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