DiseasesLymphoid Leukemia, Myeloid and Monocytic Leukemia, Leukemia, other
Principal Investigator:Steensma, David, Peter
Site Investigator(s):Amrein, Philip, C.
Attar, Eyal, C.
Dose levels for the study's second stage will be based on safety and pharmacokinetics.
IPSS low, intermediate -1, intermediate-2, or high risk MDS (including CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label
ECOG 0 to 2
No major surgery within 2 weeks of starting study treatment
No cytotoxic chemotherapy within 2 weeks of starting study treatment
Able to swallow pills
Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)
Treatment with investigational therapy within 2 weeks of study treatment
Uncontrolled medical disease(s) or active, uncontrolled infection
Diagnosed with AML
Active uncontrolled gastric or duodenal ulcer
Known history of HIV or hepatitis C or B