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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

Criteria

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