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

Study start date: November 1, 2003

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