A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia

Trial Profile

A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 24 Dec 2015

At a glance

  • Drugs Midostaurin (Primary)
  • Indications Acute lymphoblastic leukaemia; Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 21 Dec 2015 Status changed from completed to discontinued, according to ClinicalTrials.gov record.
    • 08 Dec 2015 Results presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
    • 10 Nov 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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