Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia

This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.

Inclusion Criteria:

• AML patients in first relapse or refractory after all prior therapy
• Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia
• AML secondary to prior chemotherapy for other neoplasms.
• Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy
• Prior treatment with a FLT3 targeted therapy
• Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy