Study identifier:D134BC00001
ClinicalTrials.gov identifier:NCT04924608
EudraCT identifier:2020-005607-39
CTIS identifier:2023-507336-20-00
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)
Neurofibromatosis 1
Phase 3
No
Selumetinib
All
146
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
Merck Sharp & Dohme Corp.
A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
This is a randomized, double-blind, placebo-controlled, 2 arm multicentre, global Phase III study to assess the efficacy and safety of selumetinib compared with placebo in adult participants with NF1 who have symptomatic, inoperable PN.
Location
Location
Milano, Italy, 20133
Location
Madrid, Spain, 28041
Location
Badalona, Spain, 08916
Location
Gainesville, FL, United States, 32610
Location
Saint Louis, MO, United States, 63156
Location
Rockville, MD, United States, 20852
Location
Montreal, QC, Canada, H4A 3J1
Location
Toronto, ON, Canada, M5G 2C4
Arms | Assigned Interventions |
---|---|
Experimental: Arm A Selumetinib | Drug: Selumetinib Selumetinib oral capsules (10 mg and 25 mg) Other Name: AZD6244 |
Placebo Comparator: Arm B Placebo | Other: Placebo Placebo oral capsules for Selumetinib masking (10 mg and 25 mg) |
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