Relapsed or refractory AML
Conditions
Sponsors
DAIICHI SANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: -Acute Promyelocytic Leukemia -Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive) -History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics Safety, tolerability, and pharmacokinetics -The safety of quizartinib will be assessed by CTCAE. -The maximum tolerated dose of quizartinib, and the recommended dose of quizartinib for the following clinical studies will be estimated. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory -Exploratory assessment of quizartinib-related biomarkers -Exploratory assessment of tumor response to quizartinib -Biomarker analyses will be conducted using the bone marrow aspirate specimen and blood samples. -Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood. | — |
Countries
Japan
Outcome results
None listed