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ACTIVE NOT RECRUITING
NCT04924608
PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2021-11-19

Completion Date

2029-02-15

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Selumetinib

Selumetinib oral capsules (10 mg and 25 mg)

OTHER

Placebo

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

Locations (34)

Research Site

Gainesville, Florida, United States

Research Site

Rockville, Maryland, United States

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St Louis, Missouri, United States

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Commack, New York, United States

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Melbourne, Australia

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St Leonards, Australia

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Beijing, China

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Guangzhou, China

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Shenyang, China

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Créteil, France

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Lyon, France

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Toulouse, France

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Hamburg, Germany

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Tübingen, Germany

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Würzburg, Germany

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Milan, Italy

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Naples, Italy

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Roma, Italy

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Minatoku, Japan

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Nagoya, Japan

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Shinjuku-ku, Japan

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Bydgoszcz, Poland

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Moscow, Russia

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Moscow, Russia

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Badalona, Spain

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Madrid, Spain

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London, United Kingdom

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Manchester, United Kingdom