Observational Study to evaluate the effect and safety of Selumetinib in Pediatric Patients with NF1-PNs - PEDIA

Study identifier:D1346R00016

ClinicalTrials.gov identifier:NCT06175637

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Observational Study of the Effectiveness and Safety of the MEK 1/2 Inhibitor (MEKi) Koselugo (Selumetinib) in Pediatric Patients with Symptomatic, Inoperable, Neurofibromatosis Type 1 (NF1)-Associated Plexiform Neurofibromas (PN)

Medical condition

Neurofibroma, Plexiform

Phase

N/A

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

400

Study type

Observational

Age

3 Years - 16 Years

Date

Study Start Date: 20 Dec 2023
Estimated Primary Completion Date: 30 Nov 2027
Estimated Study Completion Date: 30 Nov 2027

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria