NCT02012920

A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects With Castration-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Innocrin Pharmaceutical · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Castration-resistant Prostate Cancer
• CRPC

Interventions

Type	Name	Description
DRUG	Seviteronel: given orally once daily in 28 day cycles

Timeline

• Start date: 2011-12-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2013-12-17
• Last updated: 2019-02-01

Locations

23 sites across 4 countries: United States, Greece, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study