EUCTR2006-004572-13-LT进行中（未招募）不适用
A Phase II multi-centre, randomized, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of two loading dose regimens of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as three doses of 120 mg or 180 mg (given as 2 injections of 60 mg or 90 mg on Day 1, repeated on Days 2 & 3) in patients with advanced prostate cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •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
- •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
- •Screening QTc interval of = 430 msec
- •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
- •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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