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
- Conditions
- advanced prostate cancer
- Registration Number
- EUCTR2005-002100-42-LT
- Lead Sponsor
- Ardana Bioscience Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 8
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method