A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

Inclusion Criteria: * Willing and able to provide informed consent * Age 18 and older * Diagnosis of AML or MDS according to the WHO criteria * AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens * MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMA * Has adequate organ function: AST and ALT \< 3X the ULN, serum bilirubin \< 2X the ULN, serum creatinine of \< 2 mg/dL, or a calculated creatinine clearance of \> 50 mL/minute * ECOG Performance Score of 0 -2 * Recovered from the effects of any prior systemic therapy, radiotherapy or surgery * Willing to use physician approved birth control method Exclusion Criteria: * Current CNS Leukemia * Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia * \< 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents * Uncontrolled infection * Known HIV, hepatitis B or hepatitis C. * Other active malignancy that requires therapy * If female, is lactating or breast feeding * Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)