Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

November 19, 2021

Primary Completion Date

August 5, 2024

Study Completion Date

February 15, 2029

Conditions
Neurofibromatosis 1Plexiform Neurofibroma (PN)
Interventions
DRUG

Selumetinib

Selumetinib oral capsules (10 mg and 25 mg)

OTHER

Placebo

Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)

Trial Locations (34)

2065

Research Site, St Leonards

3000

Research Site, Melbourne

11725

Research Site, Commack

20133

Research Site, Milan

20246

Research Site, Hamburg

20852

Research Site, Rockville

28041

Research Site, Madrid

31059

Research Site, Toulouse

32610

Research Site, Gainesville

63156

Research Site, St Louis

69008

Research Site, Lyon

72076

Research Site, Tübingen

80131

Research Site, Napoli

94000

Research Site, Créteil

97080

Research Site, Würzburg

100070

Research Site, Beijing

100730

Research Site, Beijing

110001

Research Site, Shenyang

115522

Research Site, Moscow

125412

Research Site, Moscow

510060

Research Site, Guangzhou

90035-903

Research Site, Porto Alegre

14051-140

Research Site, Ribeirão Preto

045202-001

Research Site, São Paulo

M5G 2C4

Research Site, Toronto

H4A 3J1

Research Site, Montreal

00165

Research Site, Roma

105-8471

Research Site, Minatoku

466-8560

Research Site, Nagoya

160-8582

Research Site, Shinjuku-ku

85-094

Research Site, Bydgoszcz

08916

Research Site, Badalona

SE1 9RT

Research Site, London

M20 4BX

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY