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A Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; Hydrogen Sulfate in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)

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Trial Profile

A Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; Hydrogen Sulfate in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Jan 2024

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At a glance

  • Drugs Selumetinib (Primary)
  • Indications Neurofibromatosis 1; Plexiform neurofibroma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SPRINT; SPRINT Stratum 1

    • Most Recent Events

    • 03 Oct 2023 Results of 5 years of additional safety and efficacy data, published in the Neuro-Oncology
    • 08 May 2023 According to AstraZeneca media release, Selumetinib has been approved in China for treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric patients with neurofibromatosis type I aged 3 years and above. The approval by the National Medical Products Administration (NMPA) in China was based on positive results from this study.
    • 03 Apr 2023 According to an AstraZeneca media release, Health Canada has granted a Notice of Compliance (NOC) for KOSELUGO (selumetinib) for the treatment of pediatric patients aged two years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Health Canada's authorization of KOSELUGO was based on positive results from this study.
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