Brief title: RADPAC
Design: A randomized, double-blind, multi-center phase III study evaluating paclitaxel with and without RAD001 in patients with gastric carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen
No of patients: 480
This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel alone in terms of hazard ratio of overall survival in patients with gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine. Primary endpoint is the overall survival, secondary endpoints are treatment efficacy in terms of best overall response, disease control rate and progression free survival and AEs/SAEs, discontinuation rate, dose adjustment rate and tolerability.
Prof. Dr. S.E. Al-Batran
Institut für Klinisch-Onkologische Forschung
Krankenhaus Nordwest GmbH
Steinbacher Hohl 2-26