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 res t. Vitals signs, including temperature, pulse and BP to be recorded 1-hour post-study drug administration during each cycle on days 1, 29, 57, and 85. 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 monocyte s, absolute eosinophils, and absolute basophils. Samples will be analyzed locally. 5. Blood Chemistry: Should include sodium, potassium, total chloride, bicarbonate or carbon dioxide, BUN (or urea), uric acid, creatinine, glucose, total calcium, magnesium, phosphorous and phosphate, albumin, total protein, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase, total bilirubin, amylase, lipase, lactate dehydrogenase (LDH) and TSH + reflex free T4 and free T3. Samples will be analyzed locally. 6. Coagulation: Should include Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT). Samples wi ll be analyzed locally. 7. Cardiac Troponin : For participants undergoing screening, circulating levels of cardiac Troponin-I (cTnI) must be measured and found to be withi n the normal reference range within 28 days before study entry, preferably using the central laboratory kits provided. See Section 7.1.8 for full details.