EUCTR2007-004349-13-LV进行中（未招募）不适用
A Phase II multi-centre, open-label study investigating the long-term safety and efficacy of Teverelix, long-acting formulation in patients with advanced prostate cancer – follow on study to Study N°. ARD-0301-004
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
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
- Male
入选标准
- •Per protocol completion of study no. ARD-0301-004
- •Prostate cancer assessed by the clinical investigator as being adequately controlled by 4-weekly subcutaneous administration of 90 mg Teverelix LA
- •Suitable androgen deprivation therapy (advanced prostate cancer i.e. with local invasion and/or metastasis)
- •Signed, written informed consent
- •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
- •Testosterone > 2 ng/ml at Week 24 visit of ARD-0301-004 study
- •Increasing PSA levels at Week 24 visit of ARD-0301-004 study
- •Liver or renal function tests (ASAT/SGOT, ALAT/SGPT), total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis.
- •Any contraindication to the use of Teverelix LA
- •Life expectancy of less than 1 year
- •Baseline Testosterone value below 2.31 ng/ml
- •Bilateral orchidectomy
- •Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug
研究者
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