Phase 1 Study of Quizartinib

A Phase 1, Open-Label, Dose Escalation Study of Quizartinib, An Oral FLT3 Inhibitor, in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.

Inclusion Criteria:

• Relapsed or refractory AML
• AML for which no standard treatment is available
• ECOG Performance Status (PS) of 0 to 2

Exclusion Criteria:

• Acute Promyelocytic Leukemia
• chronic myelogenous leukemia in blast phase (BCR-ABL fusion gene positive)
• History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.