Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Inclusion criteria

• The patient must provide written informed consent prior to receiving Sorafenib.
• The male or female patient must be at least 18 years of age.
• The patient must have pathologically proven advanced Renal Cell Carcinoma.
• Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
• The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
• The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with Sorafenib as a single agent.
• The patient must have an Eastern Cooperative Oncology Group performance status of 0 - 2.
• The patient will not require other systemic anti-cancer chemotherapy, immunotherapy or hormonal therapy, except for bisphosphonates while taking Sorafenib.
• Both male and female patients must use adequate barrier birth control methods during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with Sorafenib.
• For patients, who have had major surgery, the wound must be completely healed prior to receiving Sorafenib treatment (4 weeks).
• The patient must have within normal Renal & Hepatic function.
• The patient must have within normal CBC.

Exclusion criteria

• Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
• Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
• Patients who have a life expectancy of less than 2 months.
• Patients with metastatic brain or meningeal tumours.
• 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.
• Non-measurable disease according to RECIST.
• Concomitant St. John's Wort (Hypericum perforatum).
• Warfarin (or similar medication) is allowed.
• 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).
• Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
• 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).
• Patients with active coronary artery disease or ischemia.
• Patients with Child-Pugh class C hepatic impairment.
• Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
• Patients with active uncontrolled hypertension.
• Patients with recent or active bleeding diathesis.
• Patients with any medical condition which could jeopardize their safety while taking an investigational drug.