Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

Inclusion Criteria:

Has reached ≥18 years old or the age of the age of majority in their country
Part 1 (dose escalation): Has FLT3-ITD mutant (≥ 3% FLT3-ITD/total FLT3) AML (primary AML, secondary, or therapy-related AML), and has treatment failure to prior AML therapy or have relapsed after prior AML therapy
Part 2 (dose expansion): Has FLT3-ITD mutant (≥3% FLT3-ITD/total FLT3) AML (primary, secondary, or therapy-related AML), and has treatment failure to prior AML therapy or have relapsed after prior AML therapy, OR has newly diagnosed AML who are ineligible for intensive induction chemotherapy
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (or 3 for patients with newly diagnosed AML between 18 and 74 years old)
Has protocol-defined adequate renal, hepatic and cardiac status
Is not pregnant, and if not postmenopausal or a surgically sterile male or female, is willing to use a highly effective contraceptive method upon enrollment, during the course of the study, and for 6 months following the last dose of investigational drug
Is able and willing to provide protocol-defined bone marrow biopsies/aspirates

Exclusion Criteria:

Has central nervous system (CNS) involvement of leukemia - patients with a history of CNS leukemia may be eligible if the CNS leukemia is adequately controlled (defined as no clinical symptoms of CNS disease and at least 2 consecutive lumbar punctures with no evidence of disease prior to study enrollment) after discussion and approval from the Sponsor
Has acute promyelocytic leukemia (AML subtype M3)
Has uncontrolled or significant cardiovascular disease or QTc interval >450 ms (average of triplicate determination)
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals.
Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection based on positive tests during Screening
Has persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapies

Has any history or medical condition, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

safety or well-being of the participant or offspring
safety of study staff
analysis of results