NL-OMON31565已完成2 期
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 rectum study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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)
- •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)
- •Women should not be pregnant or lactating
- •Being willing and able to undergo one extra biopsy
- •Have given written informed consent before patient registration
排除标准
- •the opposite of the above
研究者
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