Trial Profile

A Phase 1/2, Multicenter, 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

Status: Active, no longer recruiting

Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2024

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At a glance

Drugs Quizartinib (Primary) ; Cytarabine; Cytarabine; Daunorubicin liposomal; Etoposide; Fludarabine; Hydrocortisone; Methotrexate; Prednisolone
Indications Acute myeloid leukaemia
Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
Sponsors Daiichi Sankyo Inc

07 Nov 2024 Status changed from recruiting to active, no longer recruiting.
10 Dec 2019 Results presented at the 61st Annual Meeting and Exposition of the American Society of Hematology.
16 Aug 2019 This trial has been Discontinued in Ireland.

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