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-containing Regimen
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 progression-free survival in patients with
gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine
(e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or derivatives). Patients will be
randomized in a 1:1 ratio for a total of 240 patients per treatment arm. Randomization will
be stratified according to performance status (0-1 versus 2), prior taxan use (yes vs. no)
and lesions (measurable vs evaluable).
Study treatment will be continued until progression or intolerable toxicity. Patients will
be seen at baseline/screening, and weekly for paclitaxel administration and safety
assessment until disease progression or discontinuation of trial therapy for other reasons.
Radiological tumor assessment will be performed every second cycle (every 8 weeks) or
earlier if clinically indicated. Post-study follow-up will be completed every 8 weeks for
survival.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
overall survival
6 months follow-up
No
Salah-Eddin Al-Batran, MD
Principal Investigator
Krankenhaus Nordwest
Germany: Federal Institute for Drugs and Medical Devices
CRAD001RDE35T
NCT01248403
October 2011
January 2016
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