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Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834390
Recruitment Status : Completed
First Posted : July 15, 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 phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: quizartinib Drug: Cytarabine Drug: Idarubicin Drug: Daunorubicin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b, Open-label, Dose Escalation Study of Quizartinib in Combination With Induction and Consolidation Chemotherapy in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Study Start Date : July 2016
Actual Primary Completion Date : October 19, 2017
Actual Study Completion Date : October 19, 2017


Arm Intervention/treatment
Experimental: Arm 1

Quizartinib and Cytarabine to be used in both the Induction period and the Consolidation period.

And either Idarubicin or Daunorubicin to be used in the Induction period.

Drug: quizartinib
[Induction period] Once-daily repeated oral administration day 8 to day 21. [Consolidation period] Once-daily repeated oral administration day 6 to day 19.

Drug: Cytarabine

[Induction period] Once-daily intravenous injection of 100 mg/m2 cytarabine on day 1 to 7.

[Consolidation period] Twice-daily intravenous injection of 3.0 g/m2 cytarabine at 12-hour intervals on day 1, 3, and 5.


Drug: Idarubicin
Either Idarubicin or Daunorubicin will be used [Induction period] Once-daily intravenous injection of 12 mg/m2 idarubicin on day 1 to 3.

Drug: Daunorubicin
Either Idarubicin or Daunorubicin will be used [Induction period] Once-daily intravenous injection of 60mg/m2 daunorubicin on day 1 to 3.




Primary Outcome Measures :
  1. Number of subjects experiencing adverse events [ Time Frame: day 0 to end follow-up, approximately 1 year ]
  2. Cmax profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  3. Tmax profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  4. AUCtau profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  5. Cmax,ss profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  6. Ctrough profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  7. Tmax,ss profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886

  8. AUCtau,ss profile of quizartinib and its active metabolite [ Time Frame: Induction cycle 1 day 8 to consolidation cycle 1 day 28 ]
    Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No prior treatment for AML (including quizartinib)
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia
  • Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy.

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): NCT02834390


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02834390    
Other Study ID Numbers: AC220-A-J102
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 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
hematology
malignancy
newly diagnosed
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors