Oncolytics Biotech Inc. has announced that it has completed patient enrollment in its U.S. Phase I clinical trial using REOLYSIN in combination with FOLFIRI (Folinic Acid (leucovorin) with Fluorouracil (5-FU) and Irinotecan) in patients with oxaliplatin refractory, Kras mutant colorectal cancer (REO 022).
The trial is a 21-patient, single arm dose escalation study designed to determine a maximum tolerated dose and dose-limiting toxicities for the combination of REOLYSIN and FOLFIRI.
Eligible patients include those with histologically confirmed cancer of the colon or rectum with Kras mutation and measurable disease. They must have progressed on or within one hundred and ninety days after the last dose of an oxaliplatin regimen in the metastatic setting, or be intolerant to oxaliplatin.
The principal investigator for the study is Dr. Sanjay Goel of the Montefiore Medical Center at the Albert Einstein College of Medicine in New York.
"We are pleased to complete enrollment in this clinical study as we learn more about using REOLYSIN for the treatment of colorectal cancer," said Dr. Brad Thompson , President and CEO of Oncolytics.
Dr. Thompson continued, "Oncolytics continues to expand its colorectal cancer program and we recently announced entry into an agreement where the NCIC Clinical Trials Group would conduct an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN given in combination with FOLFOX-6 plus bevacizumab (Avastin) versus FOLFOX-6 plus bevacizumab alone."