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Clinical Trial : REO 022

REO 022 is a Phase I dose-escalation study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) plus Fluorouracil (5-FU) plus Irinotecan) and bevacizumab (Avastin®) in patients with oxaliplatin refractory or intolerant, KRAS mutant colorectal cancer. The study combines three dose levels, each with cohorts of three to six patients, to determine a maximum tolerated dose and dose-limiting toxicities with the combination of REOLYSIN®, bevacizumab and FOLFIRI. FOLFIRI and bevacizumab will be administered on days 1 and fifteen of each twenty-eight day cycle, while REOLYSIN® will be administered on days one through five. Between 20 and 32 patients will be enrolled. The primary objectives are dose-limiting toxicity, maximum-tolerated dose, and to determine the pharmacokinetic parameters of the treatment combination. Secondary objectives include progression-free and overall survival, objective response and clinical benefit rates, CEA levels, safety and tolerability. Other objectives are the determination of specific genetic mutations and aberrant signalling pathways that may serve as novel biomarkers of response and efficacy.