RAD001 versus Placebo in Advanced Gastric Cancer
Research type
Research Study
Full title
A randomized, double-blind, multi-centre phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy
IRAS ID
21627
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-006544-20
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to see whether a new drug, everolimus, is a safe and effective treatment for people with advanced gastric cancer.Currently there are no standard treatments for patients with advanced gastric cancer after the initial chemotherapy regimen has stopped working. This study will compare the effectiveness of everolimus plus best supportive care with placebo plus best supportive care. Everolimus works by blocking a reaction, which allows cancer cells to grow and divide. Everolimus has shown effects on stomach cancer in both laboratory and human studies, by slowing the growth of the cancer. Patients will receive either everolimus or placebo on a daily basis. This is a double-blind study, which means that both the patient and the doctor will not know which medication the patient is taking.Patients will visit the study hospital every four weeks for routine check-ups and every 6 weeks for scans to determine the tumour status.Each participant will receive study medication until disease progression, unacceptable side effects or withdrawal of consent. Patients will then be contacted every three months to see how the patients are.Approximately 633 patients will take part in this study in over 120 centres around the world (Europe, Asia, North and South America, Australia and New Zealand). This study is being organised by Novartis Pharma Services AG of Lichstrasse 35, 4056 Basel, Switzerland.
REC name
London - Hampstead Research Ethics Committee
REC reference
09/H0720/94
Date of REC Opinion
22 Jun 2009
REC opinion
Favourable Opinion