Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients

A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability,
Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients with Recurrent
or Refractory Acute Myelogenous Leukemia (AML).

Inclusion Criteria:

- Males or females at least 18 years of age

- Patients with relapsed or refractory Acute myelogenous leukemia (AML) or AML
secondary to myelodysplastic syndromes, myeloproliferative neoplasm, or chronic
myelogenous leukemia

- Eastern Oncology Cooperative Group (ECOG) performance status 0-2 and considered
likely to complete at least 4 weeks of therapy

Exclusion Criteria:

- With the exception of alopecia, any unresolved toxicities from prior therapy greater
than CTCAE grade 1 at the time of starting study treatment.

- As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, including uncontrolled hypertension, active bleeding diatheses, or active
infection including hepatitis B, hepatitis C and HIV.

- Active heart disease including myocardial infarction within the last 3 months,
symptomatic coronary artery disease, clinically significant arrhythmias not
controlled by medication or uncontrolled congestive heart failure

- Prior allogeneic transplant requiring immunosuppressive therapy (Patients with prior
allogeneic transplants who remain clinically stable for ≥ 2 weeks or more off
immunosuppressive therapy, are eligible)

- White blood cell count ≥ 100,000/mm3 (100x10*9/L)

- Type 1 Diabetes or uncontrolled Type II Diabetes

- HbA1C ≥8% or fasting blood glucose >160 mg/Dl (>8.9 mmol/L)

- Baseline fasting total cholesterol >300 mg/dL (>7.75 mmol/L)