Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Exclusion Criteria

• •1. Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
• •2. Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
• •3. Patients who have a life expectancy of less than 2 months.
• •4. Patients with metastatic brain or meningeal tumours.
• •5. Patients are excluded who require any of the following:
• •* Investigational drug therapy during the treatment with Sorafenib or within 30 days prior to their first dose of Sorafenib.
• •* Concomitant Rifampicin.
• •6. Non-measurable disease according to RECIST.
• •7. Concomitant St. John's Wort (Hypericum perforatum).
• •8. Warfarin (or similar medication) is allowed.
• •9. Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
• •10. Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
• •11. Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc \> 0.45 - 0.47 second).
• •12. Patients with active coronary artery disease or ischemia.
• •13. Patients with Child-Pugh class C hepatic impairment.
• •14. Patients with severe renal impairment (calculated creatinine clearance of \< 30 ml/min) or who require dialysis.
• •15. Patients with active uncontrolled hypertension.
• •16. Patients with recent or active bleeding diathesis.
• •17. Patients with any medical condition which could jeopardize their safety while taking an investigational drug.