A Study for Patients With Acute Leukemia

Inclusion Criteria:

Dose escalation period for both schedules:

• Patient must have a confirmed diagnosis of acute leukemia regardless of sub-type for whom experimental phase 1 therapy is appropriate
• Are greater than or equal to 18 years of age
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug

Dose confirmation period for both schedules:

• Participant must have a confirmed diagnosis of untreated AML, should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
• Are greater than or equal to 60 years of age
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug

Exclusion Criteria:

• Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
• Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
• Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry
• Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
• Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant
• Have uncontrolled systemic infection
• Females who are pregnant or lactating
• Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required)