Phase Ib Trial of the Combination of PI3K Inhibitor BAY80-6946 and Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer

Inclusion Criteria:

- Age greater than/equal to 18 years old

- ECOG Performance Status of 0 - 1

- Life expectancy of at least 12 weeks

- Patients with advanced, histologically or cytologically confirmed solid tumors,
refractory to any standard therapy or have no standard therapy available

- LVEF (left ventricular ejection fraction) > or = to the lower limit of normal for the
institution

- Radiographically or clinically evaluable tumor

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 14 days prior to start of first dose:

- Hemoglobin > 9.0 g/dL

- Absolute neutrophil count (ANC) > or = 1500/mm3

- Platelet count > or = 100,000 /mm3

- Total bilirubin < or = 1.5 times the upper limit of normal

- ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < or = 2.5 x
upper limit of normal (< or = 5 x upper limit of normal for patients with liver
involvement)

- PT-INR (prothrombin-international normalized ratio) and PTT (partial
thromboplastin time) < or = 1.5 times the upper limit of normal

- Serum creatinine < or = 1.5 times the upper limit of normal

Exclusion Criteria:

- History of impaired cardiac function or clinically significant cardiac disease (i.e.
congestive heart failure (CHF) NYHA (New York Heart Association) Class III or IV);
active coronary artery disease, myocardial infarction within 6 months of study entry;
new onset or unstable angina within 3 months of study entry, or cardiac arrhythmias
requiring anti-arrhythmic therapy

- Type 1 or type 2 diabetes mellitus or fasting glucose > 125 mg/dL or HgBA1c > or =
7.0

- Use of systemic corticosteroids within 2 weeks of study entry

- History of retinal vein occlusion

- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

- Active clinically serious infection

- Uncontrolled hypertension

- Positive for HIV, or chronic Hepatitis B or C

- Subjects undergoing renal dialysis

- Known bleeding diathesis

- Ongoing substance abuse

- Pregnant or breast-feeding women