Post-Authorisation Study of Paediatric Patients Initiating Selumetinib
Research type
Research Study
Full title
Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study
IRAS ID
309051
Contact name
Darren Hargrave
Contact email
Sponsor organisation
AstraZeneca AB
Duration of Study in the UK
4 years, 7 months, 16 days
Research summary
AstraZeneca AB (Sponsor) is conducting this research to learn about the long-term safety of selumetinib in a large population of children and adolescents for the long-term treatment of Neurofibromatosis Type 1 (NF1). NF1 is a genetic condition that causes tumours to grow along the nerves in the skin, brain, and other parts of the body.
This is an observational study which involves the collection of safety information by reviewing patients' medical records.
The research study is planned to go on for up to 5 years and include about 125 patients.
The study will be conducted at 2 hospitals in the UK and at a number of different locations in Europe. The study will enrol patients aged 3 to 17 years old.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0283
Date of REC Opinion
9 Nov 2022
REC opinion
Favourable Opinion