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

• Status: Completed
• Trial end date: 2017-10-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Cytarabine; Daunorubicin; Idarubicin

Criteria

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.