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

NCT02438007 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 953

Last updated 2023-03-15

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Galeterone

2550 mg galeterone tablets once daily PO

DRUG

Enzalutamide

160 mg enzalutamide capsules once daily PO

Sponsors & Collaborators

  • LTN PHARMACEUTICALS, INC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-07-31
Completion
2016-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438007 on ClinicalTrials.gov