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

The final analysis of efficacy will be performed after last patient has been treated for at
least 6 months. Additional periodic safety and efficacy data reviews will be performed for
any patients continuing to receive study drug afterwards.

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