Spots Global Cancer Trial Database for A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
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
Study ID: NCT02012920
Study Description
Brief Summary: 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).
Detailed Description: 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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
H. Lee Moffitt Cancer and Research Institute, Tampa, Florida, United States
First Urology, PSC, Jeffersonville, Indiana, United States
Wichita Urology, Wichita, Kansas, United States
Urology Cancer Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
NY Cancer and Blood Specialists, Bronx, New York, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Associated Medical Professionals of NY, Syracuse, New York, United States
Duke Cancer Institute at Cary: Medical Oncology, Cary, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Urologic Consultants of Southeastern Pennsylvania, Bala-Cynwyd, Pennsylvania, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Alexandria Hospital, Department of Oncology, Athens, , Greece
Kantonsspital St Gallen, Onkologie/ Hamatologie, St Gallen, Saint Gallen, Switzerland
The Royal Marsden Hospital - Institute of Cancer Research, Sutton, Surrey, United Kingdom
Guys and St. Thomas' NHS Foundation Trust, London, , United Kingdom
Contact Details
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