For Physicians

Text

SYNERGY Trial

To evaluate a survival benefit for custirsen in combination with first-line docetaxel treatment in approximately 1,000 patients with metastatic CRPC 

Trial Design: 

Randomized, open-label, two-arm trial of custirsen in ~1,000 chemotherapy-naive metastatic CRPC patients.

Arm A: 
Custirsen + Docetaxel + Prednisone
Arm B: 
Docetaxel + Prednisone
Primary Endpoint: 
Overall survival
Estimated Accrual Completion: 
Q4:2012
Estimated Primary Endpoint Date: 
YE 2013
Notes: 
SPA completed with the FDA
Received Fast Track Designation
FDA stated that an application supported primarily by the results of SYNERGY alone would be acceptable for submission

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