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

INTERVENTION: 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toxicity thought to be related to the study drug and which requires discontinuation of drug is found or consent is withdrawn.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. CONDITION: Unresectable and /or metastatic renal cell cancer. PRIMARY OUTCOME: The primary objective is to compare the overall survival between patients treated with BAY 43‐9006 versus placebo. SECONDARY OUTCOME: To assess changes in the patients health‐related quality of life (HRQOL) and symptom response. To evaluate Progression‐free Survival (PFS). To evaluate the best overall response rate (proportion of patients with confirmed partial and complete responses). INCLUSION CRITERIA: Patients who have a life expectancy of at least 12 weeksPatients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients must have had only one prior systemic therapy for advanced disease on which the patient progressed. Patients who have at least one uni‐dimensional measurable lesion by CT‐scan or MRI according to Response Evaluation Criteria in Solid Tumours (RECIST) Patients with Intermediate or low risk per the Motzer score.Patients who have an Eastern Co‐operative Oncology Group (ECOG) performance status of 0 or 1. Adequate hepatic function.Amylase and lipase <1.5 x the upper limit of normal.Serum creatinine <2.0 x the upper limit of normal. PT or INR and PTT <1.5 x upper limit of normal.