2023-507336-20-00招募中3 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Objective Response Rate (ORR) using volumetric MRI analysis as determined by ICR per REiNS criteria.
研究概览
简要总结
To compare the effect of selumetinib relative to placebo by assessment of confirmed partial and complete response rate (ORR) using volumetric MRI analysis as determined by ICR (per REiNS criteria) in participants with NF1 who have symptomatic, inoperable PN.
研究设计
- 分配方式
- Randomized
- 主要目的
- Safety Follow-up
- 盲法
- Double (Monitor, Carer, Analyst, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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'
排除标准
- •'- 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'
结局指标
主要结局
Objective Response Rate (ORR) using volumetric MRI analysis as determined by ICR per REiNS criteria.
Objective Response Rate (ORR) using volumetric MRI analysis as determined by ICR per REiNS criteria.
次要结局
- Change from baseline in chronic target PN pain intensity. Change from baseline in PlexiQoL total score. Objective Response Rate. Duration of Response. Progression Free Survival. Time to progression. Time to Response. Best percentage change from baseline in target PN vol. Pain palliation, pain medication use, pain interference, physical functioning, health related quality of life PROs&health status. Safety&tolerability. Plasma concentrations&PK parameters of selumetinib&Ndesmethyl selumetinib.
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (10)
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