EUCTR2009-017384-42-NL进行中（未招募）不适用
Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.A single-arm, multicenter, phase II study using a Simon two stage design. - RASTAT-C
Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum0 个研究点开始时间: 2010年2月8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
- •- Advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan containing regimens
- •- Mutation in codon 12, 13, or 61 of the k-ras gene on tumor sample
- •- Adequate condition (WHO 0-2)
- •- Adequate organ function
- •- Written informed consent
- •- Age = 18 years
- •- Progressive disease in the past 3 months
- •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
- •- Prior EGFr inhibiting therapy
- •- Symptomatic brain metastasis
- •- Using verapamil, amiodarone or drodarone
- •- Symptomatic hypothyroidism
- •- History of severe pulmonary disease
- •- History of toxicity during statin use
研究者
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Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design.colorectal cancerNL-OMON35030eids Universitair Medisch Centrum46
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