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临床试验/EUCTR2005-003166-42-DE
EUCTR2005-003166-42-DE进行中(未招募)不适用

Palliative Chemotherapy (2nd line) with Imatinib (GlivecTM) in Patients with Bile Duct Cancer. - GlivecGG

niversity of Leipzig0 个研究点目标入组 40 人开始时间: 2005年9月20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
入组人数
40

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

  • There must be a two-dimensional detectable tumor or metastasis, patient`s age must be between 18 and 75 years, patient`s general condition must be WHO < 2, live expectancy must be at least 3 months, and there must be an informed consent. Moreover, bilirubin must not be elevated more than 1 times (1.5 times in the presense of liver metastases) and ALT/AST more than 1.5 times (2.5 times in the presense of liver metastases) of the upper normal value. Creatinine must be < 133 umol/l (< 1,5 mg/dl) and creatinine clearance must be > 60 ml/min.
  • 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

  • Pregnant and lactating women, fertile men and women without adequate contraception, patients without a primary chemotherapy, tumor extent >50% of the liver or >25% of the lung, abdominal mass >10cm, CNS-metastases, ileus, non-measurable tumor extent, known intolerance to imatinib and its preservatives, second malignancy, second unstable disease, comedication with non-approved drugs, any other anti-cancer treatment, comedication with paracetamol.

研究者

发起方
niversity of Leipzig

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