EUCTR2005-002100-42-LT进行中（未招募）不适用
A Phase II single centre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as two doses of 120 mg in patients with advanced prostate cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •histologically proven adenocarcinoma of the prostate
- •androgen deprivation therapy suitable (advanced prostate cancer i.e. with local invasion or/and 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
- •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
- •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
- •neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance
- •evidence of concurrent malignancy
- •exposure to another investigational agent within the last month
- •lack of ability or willingness to give informed consent
- •anticipated non-availability for study visits/ procedures
研究者
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A Phase II single centre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as two doses of 120 mg (given as 2 injections of 60 mg on Day 1 and repeated on Day 2) in patients with advanced prostate cancerADVANCED PROSTATE CANCEREUCTR2005-005742-39-LTArdana Bioscience Ltd8
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