EUCTR2020-005607-39-IT进行中（未招募）1 期
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 Plexiforn Neurofibromas (KOMET). - KOMET
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults = 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN
- •- At least one 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 139
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- 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 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
研究者
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