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