A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 <Midostaurin> Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL)

Trial Profile

A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 <Midostaurin> Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jul 2017

At a glance

  • Drugs Midostaurin (Primary)
  • Indications Leukaemia; Mastocytosis
  • Focus Therapeutic Use
  • Most Recent Events

    • 28 Apr 2017 According to a Novartis media release, based on this and another single-arm open-label multicenter trial (profile 38826), the US Food and Drug Administration (FDA) has approved Rydapt to treat adults with advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.
    • 08 Jul 2015 Planned End Date changed from 1 Jan 2015 to 1 Dec 2017 as reported by ClinicalTrials.gov record.
    • 28 Jan 2015 Planned End Date changed from 1 Nov 2011 to 1 Jan 2015 as reported by ClinicalTrials.gov record.
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