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Keep this study
Lead
AstraZeneca
With
Merck Sharp & Dohme LLC
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
