Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects With Castration-Resistant Prostate Cancer
The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).
This is a Phase 1/2 study of seviteronel in subjects with castration-resistant prostate
cancer (CRPC). Phase 1 was a dose-escalation study enrolling subjects with CRPC that were
either "treatment naïve" (not treated with previous abiraterone or enzalutamide), or treated
with one or more of the following: abiraterone, enzalutamide, or chemotherapy.
Phase 2 is an open-label, multi-center cohort-expansion study to further determine the
efficacy and safety of seviteronel in two CRPC populations with documented rising PSA with or
without bone or soft tissue disease progression during treatment with: abiraterone or
enzalutamide for ≥ 12 weeks (Group 1) abiraterone and enzalutamide; treatment should be ≥ 12
weeks for at least one agent (Group 2)
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