Phase 1 Study of Quizartinib
- Registration Number
- NCT02675478
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Relapsed or refractory AML
- AML for which no standard treatment is available
- ECOG Performance Status (PS) of 0 to 2
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AC220 AC220 This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
PIA assessment Cycle 1: Days 1, 2, 8, 15 Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.
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.