The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide and/or abiraterone.
This is a phase 2 clinical trial of Seviteronel (an oral, potent and lyase-selective CYP17 inhibitor) in men with castration-resistant prostate cancer (CRPC) progressing on enzalutamide or abiraterone. Approximately 197 subjects will be used to assess treatment efficacy. The study will be conducted in two different clinical cohorts separated by prior exposure to enzalutamide or abiraterone, or prior exposure to enzalutamide and abiraterone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
197
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
University of Alabama
Birmingham, Alabama, United States
Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel
PSA response at any time whilst on study from the start of treatment within seviteronel defined by a ≥ 50% decrease in serum PSA.
Time frame: 6 months
The time to radiographic disease progression by RECIST 1.1 or PCWG3
Median time to radiographic disease progression evaluated by computerized tomography (CT scan) or magnetic resonance imaging (MRI) and radionuclide bone scans by RECIST 1.1 or Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: 10 months
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