EUCTR2018-001846-32-SE进行中（未招募）1 期
Treatment of NF1-related plexiform neurofibroma with trametinib; a single arm, open-label trial with the goals of volumetric partial remission and pain relief - plexifpc
VO Barnmedicin, Skånes University Hospital0 个研究点目标入组 15 人开始时间: 2018年7月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •NF1-related PN with severe - or with high suspicion of threatening -
- •manifestations
- •Informed consent given
- •Age 1:0-17:11
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •NF1-related PN does not fulfill characteristics for acceptable volumetric MRI assessments as outlined in box Criterion for volumetric assessment.
- •Lactating or pregnant or sexual active females, who do not use safe contraception. Sexual active males who do not use condom.
- •History of other malignancies than classic NF1-related WHO grade 1 tumor (i.e. PN or optic pathway glioma).
- •Subjects with a history of NF-1 related cerebral vascular anomaly (such as Moyamoya).
- •Subjects with NF-1, receiving pharmaceutical therapy for optic pathway malignancy/ies.
- •Any medication for treatment of left ventricular systolic dysfunction.
- •Administration of an investigational study treatment within 30 days preceding the first dose of the study treatment in this study.
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatment or excipients that contraindicate their participation.
- •Current active liver or biliary disease
- •History of hepatic sinusoid obstructive syndrome (venoocculsive disease) within the prior 3 months.
- •History of heparin-induced thrombocytopenia.
- •History of interstitial lung disease or pneumonitis.
- •History of or current evidence of retinal vein occlusion (RVO).
- •A history of known Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection may be enrolled.
- •Presence of condition that will interfere significantly with the absorption of drugs.
- •Evidence of cardiovascular risk, LVEF below LLN, Qtc >480 millisecond, clinical significant uncontrolled arrhythmia, congestive heart failure, acute coronary syndrome or history thereof.
研究者
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