EUCTR2021-000087-30-SE招募中1 期
eoadjuvant and postoperative treatment with dabrafenib and trametinibfor papillary craniopharyngioma
Skane University Hospital, Dept of Endocrinology0 个研究点目标入组 25 人开始时间: 2021年4月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically verified papillary craniopharyngioma
- •2. BRAFmut V600E, verified immunohistochemically and with sequencing.
- •3. Newly diagnosed tumour or recurrence after previous surgery, where additional surgery would give serious or permanent sequelae.
- •4. Age over 18 years.
- •5. Performance status acccording to ECOG 0-2
- •6. Adequate organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Ongoing treatment with prohibited drugs (strong inducers of CYP2C8 or CYP3A4).
- •2. Known cardiovascular disease where MEK-inhibitor is contraindicated, e g serious heart failure, increased QTc time, uncontrolled arrythmia, recent myocardial infarction, uncontrolled hypertension
- •3. Active bleeding
- •4. Thromboembolic event last 6 months
- •5- Known serious ocular disease
- •6. Surgery last 3 weeks
- •7. Cohort b: radiotherapy last 3 months
研究者
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