A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

Inclusion Criteria:

* Male or female patients \>/= 18 years of age.
* Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
* Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
* Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
* Patients with "Intermediate" or "Low" risk per the Motzer score.
* Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria:

* Patients who have received prior systemic treatment regimens for RCC.
* Uncontrolled/unstable cardiac disease
* Uncontrolled hypertension
* Active clinically serious infections (\> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 )
* History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
* Known history or symptomatic metastatic brain or meningeal tumours
* Patients with seizure disorder requiring medication
* Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event \>/= CTCAE Grade 3 within 4 weeks of first dose of study.
* Pregnant or breast-feeding patients