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This is an observational safety monitoring study (PASS) in children who are starting treatment with Selumetinib. It includes children aged 3 to 18 with NF1 (neurofibromatosis type 1) who have symptomatic, inoperable plexiform neurofibroma. The study has no assigned phase and is currently active but not recruiting new participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Have been diagnosed with NF1 with symptomatic, inoperable PN * Have initial treatment with selumetinib up to 6 months (i.e.182 days)prior to enrolment into the study (i.e. signature of the ICF) * Are aged 3 years and above, and are \< 18 years of age on the index date * Parent or legal guardian, as required by country-specific regulation, have provided informed consent (unless a country-specific waiver is obtained) Additional Criteria for Nested Prospective Cohort * Are at least 8 years old and * Are prior to attainment of Tanner Stage V on the index date Exclusion Criteria: * Have received treatment with a mitogen-activated protein kinase inhibitor before the index date * Are participating in an interventional study at index date