ClinicaliQ Trial Snapshot
- PASS of Paediatric Patients Initiating Selumetinib — Active Not Recruiting • Oncology • NCT05388370.
- Study monitoring safety of selumetinib (a cancer drug) in children with neurofibromatosis type 1 nerve tumours in routine clinical practice.
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What This Trial Is Studying
Neurofibromatosis type 1 (NF1) is a rare, autosomal dominant genetic disorder that is caused by germline mutations in the NF1 tumour suppressor gene, which encodes the tumour suppressor protein neurofibromin 1. Plexiform neurofibromas (PN) are histologically benign nerve sheath tumours, which typically grow along large nerves and plexi. On 5 March 2020, a centralised Marketing Authorisation Application was submitted to the European Medicines Agency (EMA), Marketing Authorisation in EU was granted on 17 Jun 2021. As part of the approval process, a Risk Management Plan (RMP) was developed and submitted…