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
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