Phase 1 Study of Quizartinib

• Status: Completed
• Trial end date: 2018-11-13
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

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.