Phase 2 study of quizartinib
Phase 2
Completed
- Conditions
- Acute myeloid leukemia (AML)
- Registration Number
- JPRN-jRCT2080223386
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Treatment with quizartinib monotherapy was well tolerated and resulted in clinically meaningful reductions in blast count in Japanese patients with FLT3-ITD positive relapsed or refractory AML.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 37
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Composite complete remission rate<br>-Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>-Best response, response rate, overall survival, event free survival, leukemia-free survival<br>-Safety<br>-Pharmacokinetics<br>-Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.<br>-To assess the safety according to CTCAE<br>-To measure the concentration of quizartinib in the peripheral blood.