• To evaluate Progression-free Survival (PFS) [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
• To evaluate the best overall response rate [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
• To assess changes in the patient's health-related quality of life [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
• Safety - (Adverse event assessment, Vital signs, Laboratory values) [ Time Frame: every 3 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: Yes ]
• Safety - Electrocardiogram (ECG) [ Time Frame: Screening Visit and End of Treatment Visit ] [ Designated as safety issue: Yes ]

• To evaluate Progression-free Survival (PFS) [ Time Frame: 31Dec2005 ] [ Designated as safety issue: No ]
• To evaluate the best overall response rate [ Time Frame: 31Mar2007 ] [ Designated as safety issue: No ]
• To assess changes in the patient's health-related [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
• To determine overall response duration and time to objective response [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
• To determine overall disease control rate [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
• Safety [ Time Frame: 30Sep2007 ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

• Drug: Sorafenib (Nexavar, BAY 43-9006)
• Drug: Placebo

Inclusion Criteria:

• Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
• Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
• Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
• Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

• Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
• Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
• Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
• Patients with a history or presence of metastatic brain or meningeal tumors
• Patients with seizure disorder requiring medication (such as anti-epileptics)
• History of organ allograft or bone marrow transplant of stem cell rescue
• Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control

• Patients who have three or more of the following:

  1. ECOG performance status greater than or equal to 2,
  2. Abnormally high lactate dehydrogenase,
  3. Abnormally high serum hemoglobin,
  4. Abnormally high corrected serum calcium,
  5. Absence of prior nephrectomy

Excluded therapies and medications, previous and concomitant:

• Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
• Significant surgery with 4 weeks of start of study
• Investigational drug therapy during or within 30 days
• Concomitant treatment with rifampin or St. John's Wort
• Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
• Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors