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Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
Sponsor: AstraZeneca
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
Selumetinib
Selumetinib oral capsules (10 mg and 25 mg)
Placebo
Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)
Locations (34)
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Gainesville, Florida, United States
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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