Intravenous Administration of REOLYSIN® in Combination with Gemcitabine for Patients with Advanced Pancreatic Cancer
In October 2012, Oncolytics 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.
The trial is a 33-patient study using a one sample, two-stage design. The primary objective of the trial is to determine the clinical benefit rate (complete response (CR) + partial response (PR) + stable disease (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.
In Februrary 2011, the Company announced that it had met the primary endpoint for the first stage of the study. In the first stage, 17 patients were to be enrolled, and best response noted. If less than three responses (defined as CR or PR or SD for 12 weeks or more) were observed, the study would have concluded that the combination was inactive and been terminated. If three or more responses were observed among the 17 patents, 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.
- November 9, 2012: A study of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic adenocarcinoma (PDF)
- October 24, 2012: Oncolytics Biotech Inc. Completes Patient Enrollment in U.S. Phase II Clinical Trial Investigating REOLYSIN® in Combination with Gemcitabine in Patients with Advanced or Metastatic Pancreatic Cancer
- December 2, 2011: Oncolytics Biotech Inc. Announces Phase 2 Clinical Trial of REOLYSIN® in Combination with Gemcitabine in Pancreatic Cancer Reaches Primary Endpoint (Press Release)