Spots Global Cancer Trial Database for Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
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Trial Identification
Brief Title: Efficacy and Safety of Selumetinib in Adults 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)
Study ID: NCT04924608
Study Description
Brief Summary: A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Gainesville, Florida, United States
Research Site, Rockville, Maryland, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Commack, New York, United States
Research Site, Melbourne, , Australia
Research Site, St Leonards, , Australia
Research Site, Porto Alegre, , Brazil
Research Site, Ribeirão Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Guangzhou, , China
Research Site, Shenyang, , China
Research Site, Creteil, , France
Research Site, Lyon, , France
Research Site, Toulouse Cedex 09, , France
Research Site, Hamburg, , Germany
Research Site, Tübingen, , Germany
Research Site, Würzburg, , Germany
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Roma, , Italy
Research Site, Minato-ku, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Bydgoszcz, , Poland
Research Site, Gdańsk, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Badalona, , Spain
Research Site, Madrid, , Spain
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Contact Details
Name: Alice P. Chen, MD
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
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