OXiGENE Receives Fast Track Designation for CA4P (fosbretabulin) Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Wednesday, April 06, 2016

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.

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