At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 137 enrolled
Drug / intervention
Orteronel +2 moredrug
Likely dose
Prednisone 5 mgfrom 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 Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Orteronel, Orteronel Placebo, and 1 other intervention for Prostate Cancer. Completed, enrolled 137 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartAug 2012
Primary CompletionSep 2013
Study CompletionSep 2016
TodayJul 2026
First PostedAug 16, 2012
Enrollment StartAug 20, 2012
Primary CompletionSep 12, 2013
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.9 years ago
Interventions
Orteroneldrug
Orteronel tablets
Orteronel Placebodrug
Orteronel placebo-matching tablets
Prednisonedrug
Prednisone 5 mg