CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,560 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.

Search/NCT01193244
NCT01193244Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Millennium Pharmaceuticals, Inc.·interventional·Posted Sep 1, 2010·Updated May 17, 2017

In Brief

A Phase 3 clinical trial evaluating Orteronel, Placebo, and 1 other intervention for Prostate Cancer. Completed, enrolled 1,560 participants across 240 sites in 40 countries.

Detailed Summary

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 7, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.8 years ago

Interventions

Orteroneldrug

Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.

Placebodrug

Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL.

Prednisonedrug

Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.