Oncolytics Biotech Inc. has announced that it has completed patient enrollment in its U.S. Phase 2 clinical trial (REO 015) using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers.
"This study was performed in part to confirm the results of our UK Phase II study, which enrolled a slightly different patient population, and to support our ongoing Phase III study in platinum resistant head and neck cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "This U.S. study examined a greater proportion of patients with prior taxane exposure than either of the other two studies we have conducted in this indication."
This trial was a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients included those with advanced or metastatic head and neck cancers that were refractory to standard therapy or for which no curative standard therapy existed. The primary objective of the Phase 2 trial was to measure tumor responses and duration of response, and to describe any evidence of antitumor activity.
The secondary objective is to determine the safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers. The results are expected to be fully reported in 2011.