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临床试验/EUCTR2006-001398-44-GB
EUCTR2006-001398-44-GB进行中(未招募)1 期

The use of Peroxisome Proliferator Activator Receptor Agonists in the management of Androgen Independent Prostate Cancer - PPAR

Barts and The London NHS Trust0 个研究点目标入组 49 人开始时间: 2006年3月31日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
49

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

入选标准

  • 1.Androgen independent prostate cancer defined as rising PSA in the presence of MAB (withdrawal of peripheral anti-androgen 6 weeks prior to enrolment if previous response to addition of peripheral anti-androgen)
  • 2.ECOG performance status 0-2 (see appendix 1 for ECOG grading)
  • 3.Asymptomatic (lower urinary tract symptoms alone excluding haematuria is acceptable)
  • 4.Rising PSA
  • 5.Willing to undertake 6 weeks monitoring prior to starting treatment
  • 6.Males = 16 years of age
  • 7.Patients who have given written informed consent
  • Are the trial subjects under 18? yes
  • 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

  • 1.Receiving thiazolidenedione therapy or other oral hypoglycaemics
  • 2.Receiving fibrate therapy for hyperlipidemia
  • 3.Symptomatic disease requiring urgent palliation
  • 4.Life expectancy < 4 months
  • 5.Severe renal or hepatic dysfunction (Creatinine >200 µmol/l, Bilirubin >3xULN, ALT or AST >4xULN)
  • 6.Cardiac failure (new or treated)
  • 7.Concurrent participation in an interventional (drug) clinical trial
  • 8.Currently receiving treatment for Diabetes Mellitus (except diet controlled)
  • 9.Patient taking Diclofenac (may substitute an alternative non-steroidal anti-inflammatory drug prior to study entry)
  • 10.Unwilling or unable to provide written informed consent

研究者

发起方
Barts and The London NHS Trust

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