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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)

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ClinicalTrials.gov Identifier: NCT02438007
Recruitment Status : Terminated
First Posted : May 8, 2015
Last Update Posted : September 28, 2017
Information provided by (Responsible Party):
Novus Therapeutics, Inc

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Galeterone Drug: Enzalutamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 953 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Galeterone Drug: Galeterone
2550 mg galeterone tablets once daily PO
Other Name: TOK-001

Active Comparator: Enzalutamide Drug: Enzalutamide
160 mg enzalutamide capsules once daily PO
Other Name: Xtandi®

Primary Outcome Measures :
  1. Radiographic Progression-free survival [ Time Frame: ≥ 8 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: ≥ 8 months ]
  2. Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: ≥ 8 months ]

Other Outcome Measures:
  1. Skeletal-related Events [ Time Frame: ≥ 8 months ]
  2. Safety measured by clinical safety laboratories and adverse events [ Time Frame: ≥ 8 months ]
  3. Prostate Specific Antigen (PSA) Response ≥ 50% [ Time Frame: ≥ 8 months ]
  4. Time to PSA progression [ Time Frame: ≥ 8 months ]
  5. Time to ECOG deterioration [ Time Frame: ≥ 8 months ]
  6. Best Overall Response by RECIST 1.1 [ Time Frame: ≥ 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438007

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Sponsors and Collaborators
Novus Therapeutics, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT02438007    
Other Study ID Numbers: ARMOR3-SV
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action