drugset / Trial / NCT01166542

Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

NCT01166542

Phase 3 Completed 167 enrolled Oncolytics Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.

Timeline

Start
2010-06
Primary completion
2012-04
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Comparator Pelareorep Other / unclassified 3e+10 unknown Intravenous