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Completed

NCT Number: NCT02675478

Phase 1 Study of Quizartinib

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

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Key information

Conditions

Relapsed AML Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Refractory AML

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AC220

Drug

Primary outcomes

  1. number of subjects experiencing adverse events

    Time frame: first dose to follow-up, approximately 1 year

  2. Cmax of quizartinib and its active metabolite

    Time frame: 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.

  3. Tmax of quizartinib and its active metabolite

    Time frame: 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.

  4. AUCtau of quizartinib and its active metabolite

    Time frame: 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.

  5. Cmax,ss of quizartinib and its active metabolite

    Time frame: 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.

  6. Ctrough of quizartinib and its active metabolite

    Time frame: 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.

  7. Tmax,ss of quizartinib and its active metabolite

    Time frame: 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.

  8. AUCtau,ss of quizartinib and its active metabolite

    Time frame: 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 outcomes

  1. FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio

    Time frame: Cycle 1: Days 1, 2, 8, 15

    Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.

  2. PIA assessment

    Time frame: Cycle 1: Days 1, 2, 8, 15

    Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.

  3. bone marrow findings

    Time frame: 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.

  4. absolute neutrophil count

    Time frame: 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.

  5. platelet count

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2016
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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