Overview

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

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Bayer
Treatments:
Interferon-alpha
Interferons
Niacinamide
Sorafenib