A Phase III randomised study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer

All patients will be randomised to receive either BAY 43-9006 400 mg (2x200 mg tablets) or matching placebo (2 tablets) administered orally twice daily in combination with Best Supportive Care. The Treatment Period for the study drug will include dosing twice daily in an uninterrupted schedule, the treatment period will be divided into 6 week cycles for the first 24 weeks of treatment. Cycles beyond 24 weeks of treatment will be 8 weeks in duration. Treatment will continue until unacceptable toxicity thought to be related to the study drug and which requires discontinuation of drug is found or consent is withdrawn. Once a patient progresses, the patient may be unblinded and given the opportunity to continue on BAY 43-9006.