EUCTR2007-000728-41-NL进行中（未招募）不适用
A phase I/II trial testing nelfinavir, an inhibitor of Akt signaling, in combination with preoperative chemoradiotherapy in patients with locally advanced rectal cancer - nelfinavir phase I/II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
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
- •Histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
- •Age >= 18 years
- •UICC T3-4 N0-2 M0
- •WHO performance status 0-2
- •Less than 10 % weight loss the last 6 months
- •No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- •Normal serum bilirubin 3x normal
- •ASAT and ALAT 2,5x normal
- •creatinin clearance >50 ml/min
- •Willing and able to comply with the study prescriptions
- •No history of prior pelvic radiotherapy
- •No known HIV infection
- •No hemophilia
- •No concurrent medication that is metabolized by the CYP3A4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
- •Statins should be stopped (except pravastatin and fluvastatin),
- •No concurrent use of St. John’s Wort (Hypericum perforatum)
- •Being willing and able to undergo one extra biopsy
- •Have given written informed consent before patient registration
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The opposite of the above.
研究者
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