ISRCTN05203252已完成1 期
Phase I placebo controlled, randomised, double-blind tolerability and efficacy study of oral artesunate in patients with colorectal carcinoma
St George's, University of London (UK)0 个研究点目标入组 22 人开始时间: 2009年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
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. Aged 21 - 80 years, male or female
- •2. With biopsy confirmed single primary site colorectal adenocarcinoma
- •3. With stages I - IIIb (defined according to conventional criteria)
- •4. With planned curative resection
- •5. With written, informed consent
排除标准
- •1. Contraindication to use of artesunate due to hypersensitivity
- •2. Pregnancy (of any stage)
- •3. History of hearing or balance problems
- •4. Immunosuppression or concomitant medication known to interact with artesunate
- •5. Weight less than 50 kg or greater than 100 kg
- •6. Severe anaemia (haemoglobin less than 8 g/dl)
- •7. Other planned intervention, apart from standard of care
- •8. Inability to give informed consent
- •9. Inability or unwillingness to take effective contraception in women of child-bearing age
- •10. Chronic kidney disease of NKF D/QOFI stage 3 or above (estimated glomerular filtration rate [eGFR] less than 60 ml/min)
- •11. Bilirubin greater than 2 x upper limit of normal in the absence of haemolysis, or known chronic liver disease
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