NL-OMON49019
招募中
2 期
The TRAIN study: Trametinib in neurofibromatosis type 1 related symptomatic plexiform neurofibromas - TRAIN study: Trametinib in plexiform neurofibroma
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- benign tumors
- 发起方
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- 入组人数
- 30
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patient with (mosaic) NF1
- •2\. Patients with a clinically significant symptomatic plexiform neurofibroma,
- •such as (but not limited to) head and neck lesions that could compromise the
- •airway or great vessels, brachial or lumbar plexus lesions that could cause
- •nerve compression and loss of function, lesions that could result in major
- •deformity (e.g., orbital lesions) or are significantly disfiguring, lesions of
- •the extremity that cause limb hypertrophy or loss of function, and painful
- •lesions. This will be determined by the treating physician.
- •3\. Signed, written informed consent
- •4\. Age: 18 or higher
排除标准
- •1\. Prior treatment with MEK inhibitor(s)
- •2\. Inability to undergo MRI and/or contraindication for MRI examinations
- •3\. History of a malignancy within 5 years of inclusion, except squamous cell
- •carcinoma of the skin, cervical premalignant lesions and other curatively
- •treated malignancy
- •4\. Prior radiotherapy less than 6 weeks prior to enrollment
- •5\. Prior major surgery less than 4 weeks prior to enrollment
- •6\. An investigational agent within the past 30 days.
- •7\. Enzyme\-inducing anticonvulsants, anti\-coagulants (including platelet
- •aggregation inhibitors) or other prohibited medication(s) or requirement for
结局指标
主要结局
未指定
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