At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 416 enrolled
Drug / intervention
RAD001 +1 moredrug
Likely dose
RAD001 10 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.
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor
In Brief
A Phase 3 clinical trial evaluating RAD001 and Placebo for Metastatic Renal Cell Carcinoma. Completed, enrolled 416 participants across 93 sites in 10 countries.
Detailed Summary
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Renal Cell Carcinoma
CountriesAustralia, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedDec 2006
Primary CompletionFeb 2008
Study CompletionOct 2011
TodayJul 2026
First PostedDec 12, 2006
Enrollment StartNov 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.6 years ago
Interventions
RAD001drug
The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.
Placebodrug