NCT00879333

Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)

A Randomized, Double-blind, Multi-center 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 1 or 2 Prior Systemic Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 656 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	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.
DRUG	Everolimus placebo	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.
DRUG	Best Supportive Care (BSC)	Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2009-04-10
• Last updated: 2015-11-03
• Results posted: 2015-04-06

Locations

122 sites across 22 countries: United States, Argentina, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom