Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older

Inclusion Criteria

• Participants with world health organization (WHO)-defined AML, 60 years of age or older, who are unlikely to benefit from standard induction therapy, defined as having at least 1 of the following:
• Greater than or equal to 75 years of age.
• Antecedent hematologic disease.
• Known adverse cytogenetic risk.
• Eastern Cooperative Oncology Group (ECOG) PS = 2.
• Participant must not have received definitive treatment for AML, defined as any prior chemotherapy with antileukemic activity.
• ECOG PS 0 to 2.
• Expected survival longer than 3 months from enrollment in the study.
• Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence.
• Male participants who agree to practice effective barrier contraception or agree to practice true abstinence.
• Voluntary written consent must be given before performance of any study-related procedure.
• Suitable venous access for the study-required blood sampling.
• Clinical laboratory values as specified below within 3 days before the first dose of any study drug:

•Total bilirubin must be less than or equal to ( =) 27 grams per liter (g/L).

• Hemoglobin >9 grams per deciliter (g/dL). Note: It was permissible to transfuse participants with red blood cells to achieve this criterion.
• White blood cell (WBC) count less than ( ) 50,000/ mcL.
• Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5* ULN or a history of coagulopathy or bleeding disorder
• Known human immunodeficiency virus (HIV) positive.
• Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
• Known hepatic cirrhosis or severe pre-existing hepatic impairment.
• Known cardiac/cardiopulmonary disease defined as 1 of the following:
• Uncontrolled high blood pressure (that is, systolic blood pressure >180 milliliter per mercury (mm Hg), diastolic blood pressure >95 mm Hg).
• Congestive heart failure New York Heart Association (NYHA) Class III or IV, or Class II with a recent decompensation that required hospitalization or referral to a heart failure clinic within 4 weeks before screening (see Section 15.4 of the protocol in Appendix 16.1.1).
• Cardiomyopathy or history of ischemic heart disease
• Participants with ischemic heart disease who had acute coronary syndrome (ACS), myocardial infarction (MI), and/or revascularization (example, coronary artery bypass graft, stent) in the past 6 months were excluded. However, participants with ischemic heart disease who had ACS, MI, and/or revascularization greater than 6 months before screening and who are without cardiac symptoms could be enrolled.
• Arrhythmia (example, history of polymorphic ventricular fibrillation or torsade de pointes). However, participants with = 500 msec, calculated according to institutional guidelines
• Left ventricular ejection fraction
• Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis.
• Body mass index >40 kilogram per square meter (kg/m^2).
• Treatment with CYP3A inducers within 14 days before the first dose of MLN4924.
• Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of study drug, except for hydroxyurea.