EUCTR2010-018491-24-NL进行中(未招募)不适用
Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells
Vrije Universiteit Medical Center0 个研究点开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
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
- •-patients with an indication for intravenous treatment with an aminobisphosphonate because of bone metastases of a malignant tumor.
- •-WHO 0, 1, 2 performance score
- •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
- •-WHO 3, 4 performance score
- •-prior or current use of aminobisphosphonates
- •-immunosuppressive medication (NSAID allowed)
- •-chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration
- •-renal insufficiency (creatinin clearance < 30 ml/min)
- •-liver enzyme abnormalities: -bilirubin > 1.5 times ULN (upper limit of normal);
- •-ASAT or ALAT > 2.5 times ULN (in absence of livermetastases);
- •-ASAT or ALAT > 5 times ULN (in presence of livermetastases)
- •-concomitant use of strong inhibitors of CYP3A4, such as itraconazol, ketoconazol, erytromycin, claritromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.
研究者
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