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

Strategic Insights -

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