Trials / Completed
CompletedNCT01193257
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,099 (actual)
- Sponsor
- Millennium Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orteronel | Orteronel tablets |
| DRUG | Prednisone | Prednisone tablets |
| DRUG | Orteronel Placebo | Orteronel placebo-matching tablets |
Timeline
- Start date
- 2010-11-15
- Primary completion
- 2013-05-16
- Completion
- 2016-02-29
- First posted
- 2010-09-01
- Last updated
- 2018-12-19
- Results posted
- 2018-12-19
Locations
78 sites across 14 countries: United States, Australia, Belgium, Canada, Czechia, Estonia, Finland, France, Greece, Hungary, Italy, Netherlands, Poland, Spain
Source: ClinicalTrials.gov record NCT01193257. Inclusion in this directory is not an endorsement.