Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Quizartinib; Drug: Cytarabine; Drug: Daunorubicin; Drug: Idarubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02834390

AC220-A-J102

Details and patient eligibility

About

This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.

Enrollment: 7 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No prior treatment for AML (including quizartinib)
• ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

Exclusion criteria

• Diagnosis of acute promyelocytic leukemia
• Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Quizartinib 20 mg/day

Experimental group

Description:

Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.

Treatment:

Drug: Idarubicin

Drug: Daunorubicin

Drug: Cytarabine

Drug: Quizartinib

Quizartinib 40 mg/day

Experimental group

Description:

Participants who received 40 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.

Treatment:

Drug: Idarubicin

Drug: Daunorubicin

Drug: Cytarabine

Drug: Quizartinib