概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- eurofibromatosis type 1, NF1, plexiform neurofibroma
- 发起方
- Erasmus MC
- 入组人数
- 30
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
/A
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 (PNF), 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
- •5\.Karnofsky performance level of \=70%
- •6\.No standard treatment options \= inoperable PNF
- •PNF that cannot be surgically completely removed without risk for substantial morbidity due to invasiveness, high vascularity or encasement of, or close proximity to, vital structures of the PNF.
- •7\.At least one measurable PNF, defined as a well\-demarcated lesion of at least 3 cm measured in one dimension.
- •8\.Able to swallow and retain orally administered medication.
- •9\.Female Subjects of Childbearing Potential must have negative pregnancy test within 7 days prior study treatment and agrees to use highly effective contraception
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 prohibited medications
- •8\.Left ventricular dysfunction, New York Heart Association Class II, III, or IV heart failure, acute coronary syndrome within the past 6 months, clinically significant uncontrolled arrhythmias, and uncontrolled hypertension.
- •9\.A history of retinal vein occlusion (RVO) or predisposing factors for RVO, including uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes
- •10\.Risk factors for gastrointestinal perforation, including history of diverticulitis, metastases to the gastrointestinal tract and concomitant use of medications with a recognized risk of gastrointestinal perforation
结局指标
主要结局
未指定
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