Groupe d'Etude en Oncologie du Quebec

Titre	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
Protocole ID	KOMET
ClinicalTrials.gov ID	NCT04924608
Type(s) de cancer	Autre
Phase	Phase III
Type étude	Clinique
Médicament	Selumetinib
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dre Maria Daniela D'Agostino daniela.dagostino.med@ssss.gouv.qc.ca
Coordonnateur(trice)
Statut	Actif en recrutement
Critètes d'éligibilité	Adults ≥ 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN At least one inoperable target PN measurable by volumetric MRI analysis Chronic target PN pain score documented for minimum period during screening period Stable chronic PN pain medication use at enrollment Adequate organ and marrow function
Critètes d'exclusion	Confirmed or suspected malignant glioma or MPNST (low grade glioma, including optic glioma not requiring systemic therapy or radiation therapy are exempt from this exclusion) History of malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence Clinically significant cardiovascular disease, including inherited coronary disease, acute coronary syndrome within 6 months prior to enrollment, uncontrolled angina, symptomatic heart failure, cardiomyopathy, severe valvular heart disease, abnormal LVEF and uncontrolled hypertension Ophthalmological findings/conditions including intraocular pressure > 21 mmHg, RPED/CSR or RVO Prior exposure to MEK inhibitors

Groupe d'étude en oncologie du Québec