NCT00117637

BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to: * Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a * Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression * Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a * Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage * Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer * Find out the level of BAY43-9006 in the blood once per month and any changes in this level * Find out whether BAY43-9006 effects are associated with specific biomarkers

Detailed description

Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Multi kinase inhibitor
DRUG	Interferon	Interferon

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-09-01
• Completion: 2009-03-01
• First posted: 2005-07-08
• Last updated: 2014-10-31
• Results posted: 2010-12-15

Locations

42 sites across 7 countries: United States, France, Germany, Poland, Russia, Ukraine, United Kingdom