A Phase II multi-centre, open-label study investigating the efficacy and safety of a new GnRH antagonist, Teverelix, long-acting formulation in patients with advanced prostate cancer
- Conditions
- ocally advanced and/or metastatic prostate cancerMedDRA version: 8.1Level: LLTClassification code 10060862Term: Prostate cancer
- Registration Number
- EUCTR2006-004264-31-LT
- Lead Sponsor
- Ardana Bioscience Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 54
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of Teverelix LA in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml) up to 28 weeks.;Secondary Objective: •To assess the effects on Prostate Specific Antigen (PSA)<br>•To assess the effects on Luteinizing Hormone (LH)<br>•To assess the safety of Teverelix LA in terms of:<br>oLocal tolerability<br>oSystemic tolerability (adverse events and changes in laboratory parameters)<br>;Primary end point(s): Generation and maintenance of castration (testosterone < 0.5 ng/ml) until Week 28
- Secondary Outcome Measures
Name Time Method