MedTrace Logo

Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

NCT00903175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2016-11-08

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

everolimus

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.

DRUG

sunitinib

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903175 on ClinicalTrials.gov