CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 471 enrolled
Drug / intervention
everolimus +1 moredrug
Likely dose
everolimus 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.

Search/NCT00903175
NCT00903175Phase 2Completed
CompareCT.gov

An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.

Novartis Pharmaceuticals·interventional·Posted May 18, 2009·Updated Nov 8, 2016

In Brief

A Phase 2 clinical trial evaluating everolimus and sunitinib for Renal Cell Carcinoma. Completed, enrolled 471 participants across 84 sites in 19 countries.

Detailed Summary

This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesArgentina, Australia, Brazil, Canada, Denmark, France, Germany, Hong Kong, Italy, Mexico, Netherlands, Peru, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.1 years ago

Interventions

everolimusdrug

Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

sunitinibdrug

Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.