NCT02984995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

December 5, 2016

Results QC Date

September 25, 2019

Last Update Submit

February 4, 2020

Conditions

Leukemia, Myeloid, Acute

Keywords

FLT3-ITDPositive refractory or relapsed acute myeloid leukemiaHematology malignancyDevelopmental Phase II

Outcome Measures

Primary Outcomes (1)

  • Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) after treatment with quizartinib.

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation

Secondary Outcomes (11)

  • Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML

  • Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML

  • Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation

  • Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 year

  • Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

    Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeks

  • +6 more secondary outcomes

Study Arms (2)

Initial dose 30 mg/day quizartinib

EXPERIMENTAL

Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.

Drug: Quizartinib

Initial dose 20 mg/day quizartinib

EXPERIMENTAL

Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.

Drug: Quizartinib

Interventions

QuizartinibDRUG

Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met.

Initial dose 20 mg/day quizartinibInitial dose 30 mg/day quizartinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Akita, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukui, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Fukushima, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Nara, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saga, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tochigi, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

Unknown Facility

Yamagata, Japan

Location

Unknown Facility

Yamanashi, Japan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

quizartinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Contact for Clinical Trial Information
Organization
Daiichi Sankyo Co., Ltd.
CTRinfo@dsi.com
908-992-6400

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 7, 2016

Study Start

December 8, 2016

Primary Completion

March 28, 2018

Study Completion

September 14, 2018

Last Updated

February 17, 2020

Results First Posted

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

JP(27)