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临床试验/EUCTR2009-014452-30-NL
EUCTR2009-014452-30-NL进行中(未招募)不适用

Safety and efficacy of the addition of simvastatin to panitumumab in k-ras mutant advanced or metastatic colorectal cancer patients.A single-arm, multicenter, phase II study using a Simon two stage design. - RASTAT-P

Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum0 个研究点开始时间: 2009年10月29日最近更新:
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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
  • Mutation in codon 12, 13 or 61 of 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 or amiodaron
  • Symptomatic hypothyroidism
  • History of interstitial lung disease
  • History of toxicity during statin use

研究者

发起方
Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum

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