| Inclusion Criteria: | 1) Males and females age greater than or equal to 18 years
2) Histopathologically documented primary or secondary AML, as defined by WHO criteria confirmed by pathology review at treating institution, meeting at least one of the following: a. Refractory to at least 1 cycle of induction chemotherapy, or b. Relapsed after at least 1 cycle of induction chemotherapy, or c. Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors
3) Patients for whom no standard therapies are anticipated to result in a durable remission, or who have failed potentially curative therapy, or who refuse standard therapy or patients for whom there is no known therapy of documented treatment benefit;
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0–3
5) In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration should be at least 2 weeks for cytotoxic agents (other than hydroxyurea), or at least 5 half-lives for noncytotoxic agents
6) Persistent chronic clinically significant toxicities from prior chemotherapy or surgery must be less than Grade 2
7) Serum creatinine less than or equal to 2.0 mg/dL
8) Total serum bilirubin less than or equal to 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement
9) Serum AST or ALT less than or equal to 3.0 × ULN unless considered due to leukemic organ involvement
10) Females of childbearing potential must have a negative pregnancy test (urine beta-hCG)
11) Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study
12) Written informed consent must be provided. Patients may sign the consent form earlier than 7 days, but not more than 28 days, prior to Day 1 (Visit 2)
13) Patients must be suitable for oral administration of study drug |