| Exclusion Criteria: | 1) Subjects with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; history of recent hemoptysis; arterial hypertension (> 140/90 mm of mercury on medications); uncontrolled endocrine diseases; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
2) Subjects with a history of a cardiovascular illness including but not confined to:congestive heart failure (New York Heart Association grade III or IV); angina pectoris or myocardial infarction within the previous year; or any clinically significant cardiac arrhythmia.
3) Subjects with QTc > 470 msec (including subjects on medication).
4) Subjects with left ventricular ejection fraction (LVEF) < 50%.
5) Subjects with leukemias or myelodysplastic syndrome.
6) Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (testing is not required if there is no suspicion of the condition).
7) Subjects with a history of autologous bone marrow transplant (BMT) within the previous five years, or subjects with organ transplants or allogeneic BMT.
8) Subjects with lung tumor lesions with increased likelihood of bleeding, including: history of hemoptysis; evidence of cavitation; and invasion of aorta or pulmonary arteries by the tumor.
9) Subjects with a history of brain metastasis or leptomeningeal disease; subjects with tumors likely to metastasize to the brain should have a scan performed within 2 months of start of study to rule out brain metastasis (for example breast, lung, melanoma, sarcoma, etc.).
10) Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs (e.g., watery diarrhea, hypokalemia, and achlorhydria (WDHA) syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery, or chemotherapy).
11) Subjects with a history of major surgery within 28 days of first receipt of study drug.
12) Nursing or pregnant women.
13) Subjects with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the opinion of the Investigator, contraindicates the use of MGCD265 Drug Product or that may render the subject at excessively high risk for treatment complications.
14) Subjects with a known hypersensitivity to any of the components of the MGCD265 Drug Product (inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, lutrol micro, and stearic acid). |