Oncolytics Biotech Inc. (“Oncolytics”) announced that enrollment has been completed in a randomized Phase 2 study of REOLYSIN in patients with advanced or metastatic colorectal cancer (IND 210). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen’s University in Kingston, Ontario.
“Colorectal cancer continues to account for a significant portion of both new cancer cases and deaths in North American men and woman, highlighting the need for ongoing research in this indication,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are grateful to our colleagues at the NCIC CTG for their efforts in completing enrollment in this study in such a timely manner.”
This study is an open-label, randomized, non-blinded, phase 2 clinical study of REOLYSIN as first-line palliative treatment for patients with advanced or metastatic colorectal cancer. A total of 103 patients were enrolled after completion of a six-patient safety run in. Patients were randomized to receive either FOLFOX-6 and bevacizumab alone (control arm) or FOLFOX-6 and bevacizumab plus REOLYSIN (test arm). Patients in both arms received standard doses of FOLFOX-6 and bevacizumab on a bi-weekly basis. Patients in the test arm also received intravenous REOLYSIN at a dose of 3x1010TCID50 on days one through five of the first, second, fourth, sixth and eighth 14-day cycles, and alternate cycles thereafter.
The primary objective of the trial is to evaluate the effect of REOLYSIN in combination with standard FOLFOX-6 and bevacizumab therapy on the progression-free survival of patients with advanced or metastatic colorectal cancer. The secondary objectives are to determine the tolerability and toxicity of the therapeutic combination; to investigate additional potential measures of efficacy, including change in CEA levels, objective response rate and overall survival; to explore potential molecular factors predictive of response, including KRAS status, by assessment of archival tumour tissue; and to assess quality of life, as measured by the EORTC QLQC30. Although accrual is complete, follow up of patients until disease progression continues.
Source: Oncolytics Biotech