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

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Galeterone</span> Compared to <span class="go-doc-concept go-doc-intervention">Enzalutamide</span> In Men Expressing Androgen Receptor Splice Variant-7 mRNA (<span class="go-doc-concept go-doc-biomarker">AR</span>-V7) Metastatic CRPC

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

    NCT ID: NCT02438007

    ORG ID: ARMOR3-SV

    Trial Conditions

    Prostate Cancer

    Trial Interventions

    Drug Synonyms Arms
    Galeterone TOK-001 Galeterone
    Enzalutamide Xtandi Enzalutamide

    Trial 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).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Galeterone Experimental Galeterone
    Enzalutamide Active 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Male

    Primary Outcome Measures

    Radiographic Progression-free survival

    Secondary Outcome Measures

    Overall Survival

    Time to Initiation of Cytotoxic Chemotherapy

    Trial Keywords