Overview

Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.
Phase:
Phase 3
Details
Lead Sponsor:
Achieve Life Sciences
OncoGenex Technologies
Collaborators:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Docetaxel
Prednisone