PHASE 1 STUDY OF DS-3032B IN COMBINATION WITH QUIZARTINIB IN SUBJECTS WITH FLT3-ITD MUTANT ACUTE MYELOID LEUKEMIA THAT ARE RELAPSED/REFRACTORY, OR NEWLY DIAGNOSED AND UNFIT FOR INTENSIVE CHEMOTHERAPY
Participants with AML that has gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study. They will also have a biomarker called FLT3 in their blood. Participants will receive a combined dose of quizartinib and another experimental drug that has not been approved by the US Food and Drug Administration yet (m). The combination of these drugs will be provided in different amounts on defined days (dosing schedules). It is expected that the combination of milademetan and quizartinib will be safe and well tolerated. It is expected that the combination may fight the leukemia better than a single drug. The study will run for approximately 3 years. There may be up to 156 participants. The study has 2 parts: - Part 1 will test approximately 24-36 participants in 10 study centers in the United States. Participants will receive two study drugs (milademetan and quizartinib) in different amounts on specific days. Information will be gathered to see what dosing schedule of the drug combination is best (maximum tolerated/recommended dose). - Part 2 of the study will confirm the recommended dosing schedule identified in Part 1 is effective. A larger number of participants will receive the recommended dose in up to an additional 15 sites worldwide as necessary, based on the enrollment rate, the population, and the standard of care available to them at the time.