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Phase 1 Study of Quizartinib

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ClinicalTrials.gov Identifier: NCT02675478
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( 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.

Condition or disease Intervention/treatment Phase
Relapsed AML Refractory AML Drug: AC220 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018


Arm Intervention/treatment
Experimental: AC220
This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.
Drug: AC220



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675478


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02675478     History of Changes
Other Study ID Numbers: AC220-A-J101
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
AML
phase 1
oncology