Study Comparing Orteronel Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer
October 16, 2012 | Oncology Practice
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Objectives:Orteronel (TAK-700) is a novel, oral nonsteroidal androgen synthesis inhibitor. This randomized, double-blind phase III trial compares orteronel with placebo in men who have progression during or after docetaxel (Taxotere) therapy. Overall survival is the primary outcome measure.
Key entry or exclusion criteria: Patients who received prior therapy with orteronel, aminoglutethimide (Cytadren), ketoconazole (Nizoral, Xolegel), or abiraterone (Zytiga) are excluded.
Locations: 79 sites.
Goal: 1,083 patients.
Study sponsor: Millennium Pharmaceuticals, Inc.
Link for more information: clinicaltrials.gov/ct2/show/NCT01193257
NIH clinical trials identifier: NCT01193257