1. Abbreviated Physical Exam ination : To be assessed every 2 months. 2. Vital signs: Includes temperature, pulse, and blood pressure (BP) to be recorded in the seated position after approximately 5 minutes of r est. On days of study drug administration, vitals signs, including temperature, pulse and BP are to be recorded 1 -hour post -study drug administration. 3. Performance status: Use Eastern Cooperative Oncology Group (ECOG) – see Appendix 2. 4. Hematology: Complete blood count (CBC) to include hemoglobin, platelets, WBC, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Samples will be analyzed locally. 5. Blood Chemistry: Should include sodium, potassium, total chloride, bicarbon ate or carbon dioxide, BUN (or urea), uric acid, creatinine, glucose ( non -fasted), total calcium, magnesium, phosphorous and phosphate, albumin, total protein, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatas e, total bilirubin, amylase, lipase, lactate dehydrogenase (LDH) and TSH + reflex free T4 and free T3. Samples will be analyzed local ly. 6. Coagulation: Should include Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin T ime (PTT). Samples will be analyzed locally. 7. Cardiac Troponin : For participants undergoing screening, circulating levels of cardiac Troponin -I (cTnI) must be measured and found to be within the normal reference range within 10 days of Month 9 and Month 12. See Section 7.1.8 for full details.