Phase 1 study of quizartinib
Phase 1
Completed
- Conditions
- Relapsed or refractory AM
- Registration Number
- JPRN-jRCT2080223088
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Quizartinib multiple-dose monotherapy was well tolerated in Japanese relapsed or refractory AML patients at doses up to 60 mg/day, and the MTD was higher than 60 mg/day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Relapsed or refractory AML
-AML for which no standard treatment is available
-ECOG Performance Status (PS) of 0 to 2
Exclusion Criteria
-Acute Promyelocytic Leukemia
-Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)
-History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method