Conditions: Advanced Gastric Cancer
Keywords: Gastric cancer, advanced gastric cancer, stomach neoplasm, stomach disease, adenocarcinoma of stomach, GI neoplasm
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 656
Healthy volunteers: no

Brief summary:
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

Detailed description:

Arms:
arm 1: All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. arm 2: All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.

Interventions: intervention 1: Everolimus intervention 2: Everolimus placebo intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. intervention 2: Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. intervention 3: Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.

Protocol document: