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Brief Title: A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
Official Title: A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients With Castration-Resistant Prostate Cancer
Study ID: NCT02361086
Brief Summary: The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).
Detailed Description: This is a Phase 1/2 study of VT-464 in chemotherapy-naïve CRPC patients who are treatment-naive or who have failed prior therapy with abiraterone and/or enzalutamide. The study will examine several parallel QD dosing regimens of VT-464 using a traditional modified "3+3" Fibonacci study design. Approximately 3 dose-levels of VT-464 will be examined in each dosing regimen that is fully enrolled.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Urology Cancer Center, Omaha, Nebraska, United States
Duke University Medical Center, Durham, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Name: Joel Eisner
Affiliation: Innocrin Pharmaceutical
Role: STUDY_DIRECTOR