NCT02445976

Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.

A Phase 2 Open-label Study to Evaluate the Efficacy and Safety of Seviteronel in Subjects With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (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 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Seviteronel: given orally once daily in 28-day cycles	Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2015-05-15
• Last updated: 2019-02-01

Locations

21 sites across 1 country: United States