CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 656 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00879333
NCT00879333Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Apr 10, 2009·Updated Nov 3, 2015

In Brief

A Phase 3 clinical trial evaluating Everolimus, Everolimus placebo, and 1 other intervention for Advanced Gastric Cancer. Completed, enrolled 656 participants across 122 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Gastric Cancer
CountriesArgentina, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2009
Enrollment StartJul 1, 2009
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.2 years ago

Interventions

Everolimusdrug

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.

Everolimus placebodrug

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.

Best Supportive Care (BSC)drug

Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.