NCT00492986

An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell Carcinoma

An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the study: The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib. Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment. Overall, participation in the study will help determine the following: * Find out if patients receiving Sorafenib will live longer * Find out if Sorafenib helps to slow the worsening of kidney cancer * Find out if Sorafenib has an effect on the tumours

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Nexavar (Sorafenib, BAY43-9006)	Multikinase inhibitor: Sorafenib mono therapy 400 mg bid

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-06-27
• Last updated: 2014-12-30

Locations

33 sites across 11 countries: Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom