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news.Adventrx Pharmaceuticals has reached an agreement under a special protocol assessment with the FDA on the design of the company's phase III clinical trial protocol of CoFactor for the first-line treatment of metastatic colorectal cancer.
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CoFactor is a biomodulator drug designed to improve the efficacy and safety of the widely used chemotherapeutic agent 5-fluorouracil (5-FU). Adventrx remains on track to initiate the phase III clinical trial in Q2 2006.
The trial will enroll 1,200 patients with metastatic colorectal cancer. Patients will be equally randomized to treatment with either CoFactor or leucovorin, plus 5-FU and bevacizumab (Roche and Genentech’s Avastin).
The primary endpoint in the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.
“We are pleased that the FDA has accepted our phase III clinical protocol for CoFactor,” said Evan Levine, Adventrx president and CEO. “The protocol for this registrational trial was optimized based on feedback from numerous discussions with thought-leading oncologists.”