This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Unnamed facility
Tokyo, Japan
number of subjects experiencing adverse events
Time frame: first dose to follow-up, approximately 1 year
Cmax of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Tmax of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
AUCtau of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Cmax,ss of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Ctrough of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Tmax,ss of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
AUCtau,ss of quizartinib and its active metabolite
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Time frame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio
Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.
Time frame: Cycle 1: Days 1, 2, 8, 15
PIA assessment
Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.
Time frame: Cycle 1: Days 1, 2, 8, 15
bone marrow findings
Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count.
Time frame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
absolute neutrophil count
Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count.
Time frame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
platelet count
Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count.
Time frame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28