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NCT01188187 · ClinicalTrials.gov registry record · Phase 3
Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,022
- Enrollment target
- 20
- Study locations
NCT01188187: Completed Phase 3 study of Prostate Cancer, sponsored by Achieve Life Sciences.
NCT01188187 is a Phase 3 study of Prostate Cancer that has completed, run by Achieve Life Sciences. The registered enrollment target is 1,022 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188187, a Phase 3 study of Prostate Cancer, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,022 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Dexamethasone
- DRUG Prednisone
- DRUG Custirsen
Study Locations (20)
California
- Teva Investigational Site 086 - Los Angeles
- Teva Investigational Site 263 - Los Angeles
- Teva Investigational Site 093 - Marina del Rey
- Teva Investigational Site 097 - San Diego
Florida
- Teva Investigational Site 106 - Fort Myers
- Teva Investigational Site 094 - Port Saint Lucie
Michigan
- Teva Investigational Site 098 - Ann Arbor
- Teva Investigational Site 112 - Detroit
South Carolina
- Teva Investigational Site 266 - Greensboro
- Teva Investigational Site 102 - Myrtle Beach
Tennessee
- Teva Investigational Site 084 - Memphis
- Teva Investigational Site 101 - Nashville
Alabama
- Teva Investigational Site 100 - Birmingham
Colorado
- Teva Investigational Site 090 - Fort Collins
Georgia
- Teva Investigational Site 096 - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,022 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01188187 record still lists
NCT01188187 is an interventional study that assigns participants to a tested intervention. Its 1,022 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (68% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT01188187 names 20 study sites across 13 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01188187 about?
NCT01188187 is a clinical study titled "Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer". 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, multicente...
What is the current status of trial NCT01188187?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,022 participants. The study started on 2010-11. Estimated completion is 2014-06.
What conditions does trial NCT01188187 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01188187?
The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Custirsen (DRUG).
Who is sponsoring clinical trial NCT01188187?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01188187 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01188187's enrollment target sits among peer trials
1,022 56th of 735 higher than 680 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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