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NCT01193244 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,560
- Enrollment target
NCT01193244: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01193244 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 1,560 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193244, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,560 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)
Primary Outcome
rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG Orteronel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,560 participants |
| Start Date | 2010-10-01 |
| Est. Completion | 2016-04-07 |
| Phase | Phase 3 |
What the finished NCT01193244 record still lists
NCT01193244 is an interventional study that assigns participants to a tested intervention. Its 1,560 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 (102% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01193244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01193244 about?
NCT01193244 is a clinical study titled "Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer". This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)
What is the current status of trial NCT01193244?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,560 participants. The study started on 2010-10-01. Estimated completion is 2016-04-07.
What interventions are being tested in trial NCT01193244?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), Orteronel (DRUG).
Who is sponsoring clinical trial NCT01193244?
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 NCT01193244's enrollment target sits among peer trials
1,560 150th of 2000 higher than 1,851 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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