Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

Exclusion Criteria

• •Previous or concurrent cancer that is distinct in primary sit or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors \[Ta (Noninvasive papillary carcinoma), Tis (Carcinoma in situ: "flat tumor") and T1 (Tumor invades subepithelial connective tissue)\] or any cancer curatively treated \> 3 years prior to study entry)
• •Patients who completed their prior systemic treatment regimen less than 30 days
• •Cardiac arrhythmias requiring anti-arrhythmic (excluding beta blockers or digoxin), symptomatic coronary artery disease or ischemia
• •Active clinically serious bacterial or fungal infections
• •Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C requiring current interferon treatment
• •Symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has a negative imaging studies within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
• •Patients with evidence or history of bleeding diathesis.
• •Patients with seizure disorder requiring medication
• •History of organ allograft
• •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •Pregnant or breast-feeding patients.
• •Excluded concomitant medications:
• •Concurrent anti-cancer chemotherapy, immunotherapy, or hormonal therapy except Bisphosphonates
• •Radiotherapy during study or within 3 weeks of start of study drug.
• •Biological response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CFS) or Granulocyte macrophage colony-stimulating factor (GM-CFS), within 3 weeks prior to study entry or during study
• •Significant surgery within 4 weeks prior to start of study drug
• •Autologous bone marrow transplant or stem cell rescue within 4 months of study
• •Investigational drug therapy during or within 4 weeks prior to first drug administration and during the study
• •St John's Wort
• •Xiao Chai Hu Tang
• •Prior and concomitant use of Bevacizumab, and all other drugs (investigational or licensed) that target Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptors, Raf-kinase inhibitors (RKI), Methyl Ethyl Ketone (MEK) or Farnesyl transferase inhibitors