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Trial record 2 of 14 for:    quizartinib

Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

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ClinicalTrials.gov Identifier: NCT02984995
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
This is a Phase 2, multi-center, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Quizartinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Quizartinib
Once-daily repeated oral administration until there is no longer clinical benefit from therapy, or until unacceptable toxicity occurs.
Drug: Quizartinib
A novel second-generation FLT3 inhibitor



Primary Outcome Measures :
  1. Composite complete remission (CRc) rate [ Time Frame: Cycle 2 and on: Day 1, within about 12 months ]
    The composite complete remission (CRc) rate in quizartinib monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia (AML) is based on bone marrow findings, absolute neutrophil count and platelet count.


Secondary Outcome Measures :
  1. Number of participants achieving best response [ Time Frame: Cycle 2 and on: Day 1, within about 12 months ]
    There are several categories for best response. The number of participants achieving each of them will be determined.

  2. Percentage of participants achieving best response [ Time Frame: Cycle 2 and on: Day 1, within about 12 months ]
    Percentage of participants achieving each categorical best response

  3. Number of participants with overall survival (OS) [ Time Frame: Event driven, within about 12 months ]
    OS from registration (enrollment) until death from any cause

  4. Number of participants with event free survival (EFS) [ Time Frame: Event driven - within about 12months ]
    EFS from registration until documented disease progression/treatment failure, relapse or death from any cause, whichever comes first

  5. Number of participants with leukemia-free survival (LFS) [ Time Frame: Event driven - within about 12 months ]
    LFS from the first documented response of <spell out acronym please> (CRc) until documented relapse or death from any cause, whichever comes first

  6. Number of participants experiencing adverse events [ Time Frame: From signing of informed consent form through 30 days after last dose, within about 12 months ]
  7. Change in the area under the plasma concentration time curve (AUC) of quizartinib and its active metabolite [ Time Frame: From Cycle 1 to Cycle 3, within about 12 months ]
    AUC measured at Cycle 1, Days 1, 2, 8, 15, 16; Cycle 2, Day 1; Cycle 3, Day 1

  8. Change in the maximum plasma concentration (Cmax) of quizartinib and its active metabolite [ Time Frame: From Cycle 1 to Cycle 3, within about 12 months ]
    Cmax measured at Cycle 1, Days 1, 2, 8, 15, 16; Cycle 2, Day 1; Cycle 3, Day 1

  9. Change in the trough plasma concentration (Ctrough) of quizartinib and its active metabolite [ Time Frame: From Cycle 1 to Cycle 3, within about 12 months ]
    Ctrough measured at Cycle 1, Days 1, 2, 8, 15, 16; Cycle 2, Day 1; Cycle 3, Day 1

  10. Change in the time to reach maximum plasma concentration (Tmax) of quizartinib and its active metabolite [ Time Frame: From Cycle 1 to Cycle 3, within about 12 months ]
    Tmax measured at Cycle 1, Days 1, 2, 8, 15, 16; Cycle 2, Day 1; Cycle 3, Day 1



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

Inclusion Criteria:

  • AML patients in first relapse or refractory after all prior therapy
  • Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia
  • AML secondary to prior chemotherapy for other neoplasms.
  • Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy
  • Prior treatment with a FLT3 targeted therapy
  • Active infection not well controlled by antibacterial, antifungal and/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): NCT02984995


Locations
Japan
Aichi, Japan
Akita, Japan
Chiba, Japan
Fukui, Japan
Fukuoka, Japan
Fukushima, Japan
Gifu, Japan
Gunma, Japan
Hiroshima, Japan
Hokkaido, Japan
Ibaraki, Japan
Kagoshima, Japan
Kanagawa, Japan
Kyoto, Japan
Miyagi, Japan
Nagasaki, Japan
Nara, Japan
Okayama, Japan
Osaka, Japan
Saga, Japan
Saitama, Japan
Shizuoka, Japan
Tochigi, Japan
Tokyo, Japan
Toyama, Japan
Yamagata, Japan
Yamanashi, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02984995     History of Changes
Other Study ID Numbers: AC220-A-J201
JAPIC CTI-163441 ( Other Identifier: JAPIC CTI )
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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. ):
FLT3-ITD
Positive refractory or relapsed acute myeloid leukemia
Hematology malignancy
Developmental Phase II

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms