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 cancer

Ardana Bioscience Ltd0 个研究点目标入组 8 人开始时间: 2005年12月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

•- 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
•- 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

发起方