At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,099 enrolled
Drug / intervention
Orteronel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Orteronel, Prednisone, and 1 other intervention for Prostate Cancer. Completed, enrolled 1,099 participants across 78 sites in 14 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Belgium, Canada, Czechia, Estonia, Finland, France, Greece, Hungary, Italy, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartNov 2010
Primary CompletionMay 2013
Study CompletionFeb 2016
TodayJul 2026
First PostedSep 1, 2010
Enrollment StartNov 15, 2010
Primary CompletionMay 16, 2013
Study CompletionFeb 29, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.8 years ago
Interventions
Orteroneldrug
Orteronel tablets
Prednisonedrug
Prednisone tablets
Orteronel Placebodrug
Orteronel placebo-matching tablets