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NCT01666314 · ClinicalTrials.gov registry record · Phase 1
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
NCT01666314: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01666314 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 137 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666314, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Primary Outcome
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Interventions
- DRUG Prednisone
- DRUG Orteronel
- DRUG Orteronel Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 1 |
What the finished NCT01666314 record still lists
NCT01666314 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01666314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666314 about?
NCT01666314 is a clinical study titled "Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer". This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
What is the current status of trial NCT01666314?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2012-08-20. Estimated completion is 2016-09-01.
What interventions are being tested in trial NCT01666314?
The interventions under investigation include: Prednisone (DRUG), Orteronel (DRUG), Orteronel Placebo (DRUG).
Who is sponsoring clinical trial NCT01666314?
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 NCT01666314's enrollment target sits among peer trials
137 420th of 2000 higher than 1,579 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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