NCT01188187

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

A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,022 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Custirsen
DRUG	Docetaxel
DRUG	Prednisone
DRUG	Dexamethasone	Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-02-01
• Completion: 2014-06-01
• First posted: 2010-08-25
• Last updated: 2016-10-14

Locations

140 sites across 12 countries: United States, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Korea, Spain, United Kingdom