Oncolytics Biotech Inc. has announced that it has completed patient enrollment in its U.S. Phase II clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017).
The trial is a 33-patient study using a one sample, two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted.
If three or more responses were observed (defined as complete response (CR) or partial response (PR) or stable disease (SD) for 12 weeks or more) among the 17 patients, the study would enroll an additional 16 patients for a total of 33 evaluable patients.
As previously disclosed, this initial endpoint was met after six evaluable patients were enrolled.
The primary objective of the trial is to determine the clinical benefit rate (CR + PR + SD) of intravenous multiple doses of REOLYSIN in combination with gemcitabine in patients with advanced or metastatic pancreatic cancer.
The secondary objectives are to determine the progression-free survival (PFS), and to determine the safety and tolerability of REOLYSIN when administered in combination with gemcitabine.
"Completion of enrollment in this study is another positive step forward for our clinical program," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "The results from this study will be cross referenced with the results of the randomized Phase II pancreatic cancer clinical study using REOLYSIN in combination with carboplatin and paclitaxel that is currently enrolling patients in the U.S."