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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02675478
Other study ID # AC220-A-J101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2016
Est. completion date November 13, 2018

Study information

Verified date November 2018
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date November 13, 2018
Est. primary completion date November 13, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AC220


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of subjects experiencing adverse events first dose to follow-up, approximately 1 year
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Primary 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. Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Secondary 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. Cycle 1: Days 1, 2, 8, 15
Secondary PIA assessment Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment. Cycle 1: Days 1, 2, 8, 15
Secondary bone marrow findings Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
Secondary absolute neutrophil count Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
Secondary platelet count Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
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