A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novus Therapeutics, Inc; Tokai Pharmaceuticals
• Treatments: 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene; Androgens

Criteria

Inclusion Criteria:

• Progressive metastatic (M1) disease on androgen deprivation therapy

• Detectable AR-V7 from circulating tumors (CTCs)

• ECOG performance status 0 or 1

Exclusion Criteria:

• Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)

• Prior treatment with chemotherapy for CRPC