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A Single Arm, Phase 2, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL)

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Trial Profile

A Single Arm, Phase 2, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jan 2022

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At a glance

  • Drugs Midostaurin (Primary)
  • Indications Mast Cell Leukemia; Mastocytosis
  • Focus Therapeutic Use

    • Most Recent Events

    • 03 Dec 2021 Results from EXPLORER, PATHFINDER, D2201 and A2213 comparing the relative efficacy of avapritinib versus midostaurin for the treatment of AdvSM using matching-adjusted indirect comparison (MAIC) methodology, presented at the 24th Annual European Congress of the International Society for
    • 28 Apr 2018 Status changed from active, no longer recruiting to completed.
    • 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.

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