EUCTR2007-001131-61-BE进行中(未招募)1 期
A national randomised multi-centre trial to assess the effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (the MAGNET trial). - MAGNET
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
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.Subjects with colorectal cancer in whom treatment with anti-EGFR targeted antibodies is being started in the metastatic or adjuvant setting.
- •2.Subjects must provide written witnessed informed consent prior to any study procedures being performed
- •3.Male or female subjects aged between 18 and 80 years
- •4.Subjects must be able to understand the study, comply with the study requirements and return to the investigational site for assessments at specified times
- •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
- •1.Subjects treated with cisplatin based chemotherapy within 6 months prior to inclusion
- •2.Subjects with renal failure, i.e. creatinine levels > 2 mg/dl or creatinine clearance < 50 mg/dl
- •3.Subjects with baseline hypomagnesemia
- •4.Subjects with baseline diarrhea, i.e. > 4 bowel movements/day
- •5.Subjects with known intolerance to magnesium supplementation
- •6.Subjects with short bowel
- •7.Subjects with known or impending bowel obstruction
研究者
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