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

Kobayashi Hiroshi0 个研究点目标入组 15 人开始时间: 2021年6月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Adults 18 years or more 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

•- Confirmed or suspected malignant glioma or MPNST (optic glioma not requiring chemotherapy 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 or more 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

发起方

Kobayashi Hiroshi