Clinical Trials /

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

NCT02438007

Description:

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).

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02438007

Trial Eligibility

Document

Title

  • Brief Title: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
  • Official Title: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)

Clinical Trial IDs

  • ORG STUDY ID: ARMOR3-SV
  • NCT ID: NCT02438007

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
GaleteroneTOK-001Galeterone
EnzalutamideXtandi®Enzalutamide

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
GaleteroneExperimental
  • Galeterone
EnzalutamideActive Comparator
  • Enzalutamide

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Radiographic Progression-free survival
Time Frame:≥ 8 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:≥ 8 months
Safety Issue:
Description:
Measure:Time to Initiation of Cytotoxic Chemotherapy
Time Frame:≥ 8 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Novus Therapeutics, Inc

Last Updated

September 28, 2017