Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas - KOMET

Study identifier:D134BC00001

ClinicalTrials.gov identifier:NCT04924608

EudraCT identifier:2020-005607-39

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Multicentre, International Study with a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)

Medical condition

Neurofibromatosis 1

Phase

Phase 3

Healthy volunteers

No

Study drug

Selumetinib

Sex

All

Actual Enrollment

146

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 19 Nov 2021
Primary Completion Date: 05 Aug 2024
Estimated Study Completion Date: 17 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp.

Inclusion and exclusion criteria