Phase I Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With Paclitaxel in Patients With Advanced Cancer

Exclusion Criteria

• •Pre-existing interstitial lung disease and/or severe impaired pulmonary function
• •History of cardiac disease; congestive heart failure (CHF) \>NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
• •Prior diagnosis of Type 1 or 2 diabetes mellitus, hyperglycemia (defined as consistent fasting blood or plasma glucose \> 125 mg/dL) or HgBA1c ≥ 7%
• •Active clinically serious infections Grade ≥ 2 (NCI-CTCAE version 4.0), including viral hepatitis
• •Poorly controlled seizure disorder
• •Poorly controlled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
• •Known human immunodeficiency virus (HIV) infection or chronic hepatitis C or B
• •Subjects undergoing renal dialysis
• •Known bleeding diathesis
• •Pregnant or breast feeding women.