Conditions: Acute Myelogenous Leukemia
Keywords: Drug Therapy
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 64
Healthy volunteers: no

Brief summary:
The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60 years of age or older.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: MLN4924 intervention 2: Azacitidine
Intervention descriptions: intervention 1: MLN4924 intravenously (IV) in AML participants in a 28-day cycle:

* MLN4924 on Days 1, 3, and 5 for Cycle 1 and all subsequent cycles intervention 2: Azacitidine (IV) or subcutaneously in AML participants in a 28-day cycle:

\- Azacitidine Days 1, 2, 3, 4, 5, 8, 9 in Cycle 1 and for all subsequent cycles

Protocol document: