A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

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:

- ECOG performance status greater than or equal to 2,

- Abnormally high lactate dehydrogenase,

- Abnormally high serum hemoglobin,

- Abnormally high corrected serum calcium,

- Absence of prior nephrectomy

- Excluded therapies and medications, previous and concomitant:

- Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except
biphosphonates

- 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