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NCT01193257 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,099
- Enrollment target
NCT01193257: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01193257 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 1,099 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193257, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,099 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
Primary Outcome
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
Interventions
- DRUG Prednisone
- DRUG Orteronel
- DRUG Orteronel Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,099 participants |
| Start Date | 2010-11-15 |
| Est. Completion | 2016-02-29 |
| Phase | Phase 3 |
What the finished NCT01193257 record still lists
NCT01193257 is an interventional study that assigns participants to a tested intervention. Its 1,099 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01193257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01193257 about?
NCT01193257 is a clinical study titled "Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.". This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
What is the current status of trial NCT01193257?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,099 participants. The study started on 2010-11-15. Estimated completion is 2016-02-29.
What interventions are being tested in trial NCT01193257?
The interventions under investigation include: Prednisone (DRUG), Orteronel (DRUG), Orteronel Placebo (DRUG).
Who is sponsoring clinical trial NCT01193257?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01193257's enrollment target sits among peer trials
1,099 265th of 2000 higher than 1,736 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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