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Clinical Trials/jRCT2080223386
jRCT2080223386
Completed
Phase 2

Phase 2 open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia

DAIICHI SANKYO Co.,Ltd.1 site41 target enrollmentStarted: TBDLast updated:
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Overview

Phase
Phase 2
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Composite complete remission rate
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Intervention Model
Multi-center, single-arm, open label
Primary Purpose
Treatment Purpose

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
All

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.
  • •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.

Outcomes

Primary Outcomes

Composite complete remission rate

Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.

Secondary Outcomes

  • Safety
  • Pharmacokinetics
  • Tumor response

Investigators

Study Sites (1)

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