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