EUCTR2004-001648-64-LTActive, not recruitingNot Applicable
A Phase II multicentre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix 90 mg, long-acting formulation administered intramuscularly in patients with advanced prostate cancer
ardana LTD0 sites14 target enrollmentStarted: September 24, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •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
Exclusion Criteria
- •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 8 nmol/l
- •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
Investigators
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