A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC (ARMOR3-SV)

Ltn Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Enzalutamide; Drug: Galeterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02438007

ARMOR3-SV

Details and patient eligibility

About

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).

Enrollment: 953 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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953 participants in 2 patient groups

Galeterone

Experimental group

Treatment:

Drug: Galeterone

Enzalutamide

Active Comparator group

Treatment:

Drug: Enzalutamide