Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Inclusion Criteria:

- Patients with advanced (unresectable, recurrent or metastatic) RCC

- Patients reasonably likely to benefit from treatment with sorafenib as a single agent
therapy

- Patients with an ECOG performance status of 0-2

- Patients who will not require other systemic anticancer therapy (except for
bisphosphonates) while taking sorafenib

- Patients with vascular diseases such as wet macular degeneration, vasculitis, or new
peptic ulcer, may be enrolled but require close monitoring in accordance with
established medical practice

Exclusion Criteria:

- Patients who are currently enrolled in, are eligible for, or have access to, any
other sorafenib clinical trial

- Patients who have participated in any other sorafenib trial

- Patients who have had prior therapy with investigational agent(s) within the last
four weeks prior to study entry

- Life expectancy of less than two months

- Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0

- Patients with active coronary artery disease or ischemia

- Patients with Child-Pugh class C hepatic impairment

- Patients with severe renal impairment or who require dialysis

- Patients with active uncontrolled hypertension

- Patients with recent or active bleeding diathesis