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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 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 137 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666314
The ClinicalTrials.gov registry entry for NCT01666314 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01666314 reports 0 study locations.
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.
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