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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Quizartinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02984995

JAPIC CTI-163441 (Other Identifier)

AC220-A-J201

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Initial dose 30 mg/day quizartinib

Experimental group

Description:

Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.

Treatment:

Drug: Quizartinib

Initial dose 20 mg/day quizartinib

Experimental group

Description:

Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.

Treatment:

Drug: Quizartinib