NCT00719264

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

A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-11-12
• Primary completion: 2011-12-31
• Completion: 2013-04-15
• First posted: 2008-07-21
• Last updated: 2017-03-20
• Results posted: 2014-05-07

Locations

109 sites across 21 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