At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Orteronel+Prednisonedrug
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 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Orteronel+Prednisone for Prostate Cancer. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartMay 2012
Primary CompletionJan 2015
TodayJul 2026
First PostedMar 9, 2012
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.3 years ago
Interventions
Orteronel+Prednisonedrug
Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.