| Exclusion Criteria: | 1) The subject has received chemotherapy or a TKI </= 7 days or radiotherapy </= 28 days prior to the start of study drug or has not recovered (to </= NCI-CTCAE Grade 1 severity) from the acute toxicities associated with any prior treatments including approved therapies, investigational agents, and prior stem cell or bone marrow transplant.
2) ***continued from above: The following exceptions apply: Hydroxyurea is permitted at any time prior to study enrollment; Glucocorticoids (natural or synthetic) are allowed up to 48 hours prior to the start of study drug (with the exception of steroids for pre-medication and topical/nasal steroid use which are allowed at any time)
3) The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease) </= 28 days prior to the first dose of study drug.
4) The subject has New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
5) Myocardial infarction within 3 months of the start of study drug.
6) The subject has an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant.
7) The subject has any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose subjects to unacceptable safety risks or compromise compliance with the protocol.
8) The subject is known to be positive for the human immunodeficiency virus.
9) If female, the subject is pregnant or lactating.
10) The subject has a known allergy or hypersensitivity to any component of the investigational drug product. |