EUCTR2016-001563-36-Outside-EU/EEA进行中（未招募）1 期
A Phase II Study of RAD001 in the Treatment of Patients With Plexiform Neurofibromas (PN) Associated With Neurofibromatosis Type 1 (NF1)
ovartis Pharmaceuticals0 个研究点目标入组 26 人开始时间: 2016年5月12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
- 26
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
- •1. Clinically definite diagnosis of NF1 according to the NIH consensus conference criteria.
- •2. Patients must have PN that have the potential to cause significant morbidity, such as lesions that could compromise the airway or the great vessels, lesions that could cause nerve compression, lesions that could result in major deformity or significant cosmetic problems
- •3. Measurable disease: patient must have at least one measurable PN amenable to volumetric MRI analysis.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Chronic treatment with systemic steroids or another immunosuppressive agent.
- •2. Evidence of an active optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy.
- •3. Clinical evidence of significantly impaired lung function
- •4. Pregnancy or breast feeding.
- •5. Prior therapy with mTOR inhibitors (e.g.sirolimus, temsirolimus, everolimus).
- •6. No contraindications for MRI assessments
研究者
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