Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer (SYNERGY)
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ClinicalTrials.gov Identifier: NCT01188187 |
Recruitment Status :
Completed
First Posted : August 25, 2010
Last Update Posted : October 14, 2016
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | August 23, 2010 | |||||||||
First Posted Date ICMJE | August 25, 2010 | |||||||||
Last Update Posted Date | October 14, 2016 | |||||||||
Study Start Date ICMJE | November 2010 | |||||||||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Kaplan-Meier Estimates for Time to Death (Overall Survival) [ Time Frame: Randomization (approximately Day -12) to longest survival follow-up (Day 971). ] Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
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Original Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: 31 months ] To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.
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Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer | |||||||||
Official Title ICMJE | A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer | |||||||||
Brief Summary | This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms. | |||||||||
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 * |
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* 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 | Completed | |||||||||
Actual Enrollment ICMJE |
1022 | |||||||||
Original Estimated Enrollment ICMJE |
800 | |||||||||
Actual Study Completion Date ICMJE | June 2014 | |||||||||
Actual Primary Completion Date | February 2014 (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 | Belgium, Canada, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01188187 | |||||||||
Other Study ID Numbers ICMJE | OGX-011-11 TRANSFERRED | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Current Responsible Party | Achieve Life Sciences | |||||||||
Original Responsible Party | Siyu Liu, M.D., Ph.D., Vice President, Innovative Research & Development and Head of Global Clinical Operation, Teva Branded Pharmaceutical Products R&D | |||||||||
Current Study Sponsor ICMJE | Achieve Life Sciences | |||||||||
Original Study Sponsor ICMJE | Teva Branded Pharmaceutical Products R&D, Inc. | |||||||||
Collaborators ICMJE | Teva Branded Pharmaceutical Products R&D, Inc. | |||||||||
Investigators ICMJE |
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PRS Account | Achieve Life Sciences | |||||||||
Verification Date | October 2016 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |