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

NCT ID: NCT02984995

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-08
• Study Completion Date: 2018-09-14

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial dose 30 mg/day quizartinib

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.

Group Type: EXPERIMENTAL

Quizartinib

Intervention Type: DRUG

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 quizartinib

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.

Group Type: EXPERIMENTAL

Quizartinib

Intervention Type: DRUG

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.

Interventions

Quizartinib

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JAPIC CTI-163441

Identifier Type: OTHER

Identifier Source: secondary_id

AC220-A-J201

Identifier Type: -

Identifier Source: org_study_id