A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS
Primary Objective
This study plans to learn more about an investigational drug, called quizartinib, that may help to treat AML. An investigational drug is a medication that is still being studied and has not yet been approved for use in your country by the United States Food and Drug Administration (FDA). The FDA allows quizartinib to be used in research. Quizartinib was designed to work against cancer cells that have a FLT3-ITD mutation (a change in one of the genes).
Details
Locations
Childrens Hospital Colorado
Principal Investigator
Margaret Macy
Study ID
Protocol Number: 19-2157
More information available at ClinicalTrials.gov: NCT03793478
Categories
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