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临床试验/EUCTR2016-002552-24-FR
EUCTR2016-002552-24-FR进行中(未招募)1 期

Pemetrexed (Alimta®) in maintenance in patients with impaired renal function: multicenter randomized Phase 4 study comparing two strategies for dose calculation - PKAPIR

Centre Georges François Leclerc0 个研究点开始时间: 2017年1月5日最近更新:
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

  • Patient over 18 years
  • patient with a non-small cell lung cancer predominantly non-squamous histologically documented
  • Patient planned to start a treatment or ongoing maintenance treatment with pemetrexed
  • Neutrophils> 1500 / mm3; platelets> 100,000 / mm3
  • Written informed consent signed and dated
  • For patients of childbearing age, effective contraception
  • Creatinine clearance according to Cockcroft-Gault formula between 70 and 45 mL / min
  • PS=0 or 1
  • 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

  • Patient contraindicated with pemetrexed treatment
  • Patient with symptomatic brain metastases
  • Pregnant or nursing women
  • Patient under guardianship or submitted to major people protection regime
  • Patient not affiliated with a social security scheme (beneficiary or beneficiary)

研究者

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