Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment

The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.

Inclusion criteria:

• Histological proven gastric adenocarcinoma
• Progressive disease during/ after prior treatment
• Treated with 1 or 2 chemotherapy regimen for advanced disease
• At least one measurable lesion by RECIST criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria:

• History of another primary malignancy within 3 years
• Treated with 3 or more regimens for advanced gastric cancer
• Chronic treatment with steroids or another immunosuppressive agent
• A known history of HIV or hepatitis B seropositive, or active hepatitis C infection
• Patients with active, bleeding diathesis

Other protocol-defined inclusion/exclusion criteria may apply