Phase 1 Study of Quizartinib

Refractory AML Clinical Trial

Official title:

A Phase 1, Open-Label, Dose Escalation Study of Quizartinib, An Oral FLT3 Inhibitor, in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675478
• Other study ID #: AC220-A-J101
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Refractory AML
• Relapsed AML

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