Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
NCT02445976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197
Last updated 2019-02-01
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Prostate Cancer Foundation
collaborator OTHER -
Prostate Cancer Clinical Trials Consortium
collaborator OTHER -
Innocrin Pharmaceutical
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2018-12-31
- Completion
- 2019-01-31
Countries
- United States
Study Locations
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