Oncolytics Biotech Inc. Announces Phase II Trial for Pancreatic Cancer Treatment

Oncolytics Biotech Inc. has begun enrollment in a 2-Arm randomized Phase II study of carboplatin, paclitaxel plus REOLYSIN versus carboplatin and paclitaxel alone in the first-line treatment of patients with recurrent or metastatic pancreatic cancer. The trial is sponsored by the U.S. National Cancer Institute and is an open-label, multi-institution study aiming to improve long-term survival for patients with a poor prognosis.

Key Takeaways:

• The study is a 2-Arm Phase II randomized trial that will enroll approximately 70 patients with metastatic pancreatic cancer.
• Patients will be randomized to receive either carboplatin, paclitaxel plus REOLYSIN (Arm A) or carboplatin and paclitaxel alone (Arm B).
• The primary objective of the trial is to assess improvement in progression-free survival with REOLYSIN, carboplatin, and paclitaxel relative to carboplatin and paclitaxel alone.
• Secondary endpoints include overall response rate and overall survival.
• Dr. Tanios Bekaii-Saab, Medical Director of Gastrointestinal Oncology at The Ohio State University Comprehensive Cancer Center, is the principal investigator of the trial.
• The study aims to evaluate the efficacy of REOLYSIN in combination with carboplatin and paclitaxel in improving long-term survival for patients with metastatic pancreatic cancer.

Statistics:

• The trial will enroll approximately 70 patients.
• Patients will receive treatment every three weeks (21-day cycles).
• Tumor response assessment will be done by CT scan and conducted every eight weeks.
• The primary endpoint is progression-free survival in both arms.

Sources:

• Clinical Trials Week editors and staff reports, Copyright 2011, Clinical Trials Week via NewsRx.com