Japanese BAY80-6946 Monotherapy Phase I Study

Exclusion Criteria

• •Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia).
• •Radiotherapy to target lesions during study or within 4 weeks of first study treatment
• •Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
• •Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level \>125 mg/dL at screening, and/or HbA1c\>/= 6.5%
• •Past and current histories of cardiac disease congestive heart failure \> New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
• •Active and clinically serious infections \>Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 4.03)
• •Uncontrolled hypertension defined as systolic blood pressure \>150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal medical management
• •Patients undergoing renal dialysis
• •Pregnant or breast feeding women