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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method
To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) for the primary end point. Responders may continue the treatment.
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
|Pinnacle Oncology||Scottsdale, Arizona 85258|