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Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

NCT00719264 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2017-03-20

Study results available
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Summary

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Conditions

  • Carcinoma
  • Adenocarcinoma
  • Renal Cell
  • Nephroid Carcinoma
  • Hypernephroid

Interventions

DRUG

RAD001(everolimus)

10 mg qd

DRUG

interferon alfa-2a

dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3

DRUG

bevacizumab

10 mg/kg every 2 weeks

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
2008-11-12
Primary Completion
2011-12-31
Completion
2013-04-15

Countries

  • United States
  • Belgium
  • Brazil
  • Czechia
  • Egypt
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Netherlands
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00719264 on ClinicalTrials.gov