We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2017 by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02984995
First Posted: December 7, 2016
Last Update Posted: November 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
  Purpose
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 Intervention Phase
Leukemia, Myeloid, Acute Drug: Quizartinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • 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:
  • 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.

  • 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

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

  • 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

  • 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

  • Number of participants experiencing adverse events [ Time Frame: From signing of informed consent form through 30 days after last dose, within about 12 months ]
  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 41
Study Start Date: December 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


Contacts
Contact: Daiichi Sankyo Contact for Clinical Trial Information +81 362251111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Locations
Japan
Recruiting
Aichi, Japan
Recruiting
Akita, Japan
Recruiting
Chiba, Japan
Recruiting
Fukui, Japan
Recruiting
Fukuoka, Japan
Recruiting
Fukushima, Japan
Recruiting
Gifu, Japan
Recruiting
Gunma, Japan
Recruiting
Hiroshima, Japan
Recruiting
Hokkaido, Japan
Recruiting
Ibaraki, Japan
Recruiting
Kagoshima, Japan
Recruiting
Kanagawa, Japan
Recruiting
Kyoto, Japan
Recruiting
Miyagi, Japan
Recruiting
Nagasaki, Japan
Recruiting
Nara, Japan
Not yet recruiting
Okayama, Japan
Recruiting
Osaka, Japan
Recruiting
Saga, Japan
Recruiting
Saitama, Japan
Recruiting
Shizuoka, Japan
Recruiting
Tochigi, Japan
Recruiting
Tokyo, Japan
Recruiting
Toyama, Japan
Recruiting
Yamagata, Japan
Recruiting
Yamanashi, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
  More Information

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 Submitted: December 5, 2016
First Posted: December 7, 2016
Last Update Posted: November 16, 2017
Last Verified: November 2017

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