Carcinoma, Renal Cell Clinical Trial
Official title:
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.
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
Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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