NCT00352859

Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib

A Randomized Discontinuation Trial to Determine the Clinical Benefit of Continuation of Sorafenib Following Disease Progression in Patients With Advanced Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon	Continue sorafenib with addition of gemcitabine or interferon
DRUG	Gemcitabine or Interferon (only)	Discontinue Sorafenib and receive Gemcitabine or Interferon only

Timeline

• Start date: 2006-08-01
• Completion: 2006-11-01
• First posted: 2006-07-17
• Last updated: 2014-12-30

Locations

1 site across 1 country: United States