The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215. The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.
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Phase 1 Part: Maximum Tolerated Dose (MTD) of Gilteritinib
Timeframe: Day 1 up to the end of Induction period cycle 1 (up to 42 days)
Phase 1 Part: Recommended Expansion Dose (RED) of Gilteritinib
Timeframe: Day 1 up to the end of Induction period cycle 1 (up to 42 days)
Phase 1 Part: Number of Participants With Dose Limiting Toxicities (DLTs) of Gilteritinib
Timeframe: Day 1 up to the end of Consolidation Cycle 1 (approximately up to 4 months)
Phase 1 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years)
Phase 2 Part: Complete Remission (CR) Rate: Induction Period
Timeframe: From the date of first dose up to the start of Consolidation (approximately up to 4 months)