Relapsed AML, Refractory AML
Conditions
Keywords
AML, phase 1, oncology
Brief summary
This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
Interventions
DRUGAC220
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau,ss of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| Tmax of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| AUCtau of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| Cmax,ss of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| Ctrough of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| Tmax,ss of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
| number of subjects experiencing adverse events | first dose to follow-up, approximately 1 year | — |
| Cmax of quizartinib and its active metabolite | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PIA assessment | Cycle 1: Days 1, 2, 8, 15 | Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment. |
| bone marrow findings | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. |
| absolute neutrophil count | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. |
| platelet count | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. |
| FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio | Cycle 1: Days 1, 2, 8, 15 | Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment. |
Countries
Japan
Outcome results
None listed