Inadequate organ function, evidenced by the following laboratory results: a. Absolute neutrophil count < 750 cells/mm3. b. Platelet count < 75,000 cells/mm3. c. Total bilirubin greater than twice the upper limit of normal (ULN; unless the subject has documented Gilbert’s syndrome). d. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases). e. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in s ubjects with liver metastases, or >10 × ULN in subjects with bone metastases). f. Serum creatinine > 2.0 mg/dL or 177 μmol/L. g. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3. 6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. To control hypertension, it is recommended to first start propranolol SR 80 mg daily prior to initiating other hypertensive medications. 7.