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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)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02438007
First Posted: May 8, 2015
Last Update Posted: September 28, 2017
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.
Information provided by (Responsible Party):
Novus Therapeutics, Inc
  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).

Condition Intervention Phase
Prostate Cancer Drug: Galeterone Drug: Enzalutamide Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Novus Therapeutics, Inc:

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

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

Other Outcome Measures:
  • 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 ]

Enrollment: 953
Study Start Date: June 2015
Study Completion Date: November 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


  Show 117 Study Locations
Sponsors and Collaborators
Novus Therapeutics, Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT02438007     History of Changes
Other Study ID Numbers: ARMOR3-SV
First Submitted: March 19, 2015
First Posted: May 8, 2015
Last Update Posted: September 28, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs