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
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Sponsor:
Novus Therapeutics, Inc
Information provided by (Responsible Party):
Novus Therapeutics, Inc
Tracking Information | |||
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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 |
Radiographic Progression-free survival [ Time Frame: ≥ 8 months ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures |
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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 |
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Condition ICMJE | Prostate Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
953 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |