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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438007
Recruitment Status : Terminated
First Posted : May 8, 2015
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE March 19, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)		 Radiographic Progression-free survival [ Time Frame: ≥ 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • Overall Survival [ Time Frame: ≥ 8 months ]
  • Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: ≥ 8 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2015)
  • Skeletal-related Events [ Time Frame: ≥ 8 months ]
  • Safety measured by clinical safety laboratories and adverse events [ Time Frame: ≥ 8 months ]
  • Prostate Specific Antigen (PSA) Response ≥ 50% [ Time Frame: ≥ 8 months ]
  • Time to PSA progression [ Time Frame: ≥ 8 months ]
  • Time to ECOG deterioration [ Time Frame: ≥ 8 months ]
  • Best Overall Response by RECIST 1.1 [ Time Frame: ≥ 8 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
Official Title  ICMJE 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)
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Galeterone
    2550 mg galeterone tablets once daily PO
    Other Name: TOK-001
  • Drug: Enzalutamide
    160 mg enzalutamide capsules once daily PO
    Other Name: Xtandi®
Study Arms  ICMJE
  • Experimental: Galeterone
    Intervention: Drug: Galeterone
  • Active Comparator: Enzalutamide
    Intervention: Drug: Enzalutamide
Publications * Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)		 953
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)		 148
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02438007
Other Study ID Numbers  ICMJE ARMOR3-SV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novus Therapeutics, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novus Therapeutics, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novus Therapeutics, Inc
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP