OXiGENE Receives Fast Track Designation for CA4P (fosbretabulin)

oncologynews
 

Status: Granted fast track designation for the treatment of platinum-resistant ovarian cancer

Significant Data:

• The company plans to conduct a randomized, double-blind, placebo-controlled study divided into two parts to maximize the speed of data collection.
• Stage 1 (n=up to 80 patients), serial interim analyses will be conducted to initially assess the efficacy and safety of the combination regimen when compared with standard of care.
• Stage 2 (n=approximately 356 patients) is a confirmatory Phase III study that would begin immediately after evidence of safety and efficacy is initially demonstrated in stage 1.
• The study is designed to build upon data from the GOG-0186I study, which demonstrated that CA4P improves progression-free survival in women with recurrent ovarian cancer when combined with bevacizumab (Avastin, Genentech) compared with bevacizumab alone.