Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
- Conditions
- Prostate Cancer
- Registration Number
- NCT02445976
- Lead Sponsor
- Innocrin Pharmaceutical
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 197
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel 6 months PSA response at any time whilst on study from the start of treatment within seviteronel defined by a ≥ 50% decrease in serum PSA.
The time to radiographic disease progression by RECIST 1.1 or PCWG3 10 months 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Tulane University
🇺🇸New Orleans, Louisiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates
🇺🇸Hampton, Virginia, United States
GU Research Network
🇺🇸Omaha, Nebraska, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States