| Exclusion Criteria: | 1) Candidates for up front high dose induction chemotherapy. MDS patients who are scheduled to receive decitabine prior to a bone marrow transplant or stem cell transplant are allowed.
2) History of treatment failure with decitabine.
3) Received any experimental agent within the preceding 30 days prior to screening.
4) Uncontrolled cardiac or pulmonary disease.
5) History of intestinal surgery, pancreatic surgery, or gastric surgery.
6) Any clinically relevant disease, disorder (including psychiatric disorders), or condition, in the opinion of the Investigator, which may interfere with the objectives of the study, especially with the gastrointestinal (GI) absorption of the study drug, and/or with the safety of the subject in the study.
7) Current active colitis of any etiology (Clostridium difficile colitis, ulcerative colitis, Crohns disease, etc.) or a recent (< 2 weeks) episode of colitis.
8) Pregnant or lactating. Female patients of childbearing potential must have had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to dosing.
9) Known positive serology for human immunodeficiency virus (HIV).
10) Active viral, fungal, or bacterial infection. No patient may enter the study unless infections have been fully treated. |