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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004572-13-LT

Enrollment

Registered

2006-09-06

Start date

2006-11-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced and/or metatstatic prostate cancer MedDRA version: 8.1 Level: LLT Classification code 10060862 Term: Prostate cancer

Interventions

Product Name: Teverelix LA Product Code: ARD-0301 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Teverelix trifluoroacetate Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

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 • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: -To assess the duration of action of two different initial “loading” dose regimens of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml) in patients with prostate cancer;Secondary Objective: -To assess the pharmacodynamics of Teverelix in terms of ability to suppress and maintain plasma testosterone levels below castration level (<0.5 ng/ml) until (after week 3), 2 consecutive, increasing T levels above castration level, with the latter one above 2ng/ml have been recorded. -To assess the effects on Luteinising Hormone (LH) -To assess the effects on Prostate Specific Antigen (PSA) -To assess the safety of Teverelix LA in terms of local tolerability and systemic tolerability (adverse events and changes in laboratory parameters);Primary end point(s): Duration of castration (ie T < 0.5 ng/ml) Escape from castration is defined as, after week 3, two consecutive increasing T levels above castration level, have been recorded, with the latter one above 2ng/ml.	—

Measure

Time frame

Main Objective: -To assess the duration of action of two different initial “loading” dose regimens of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml) in patients with prostate cancer;Secondary Objective: -To assess the pharmacodynamics of Teverelix in terms of ability to suppress and maintain plasma testosterone levels below castration level (<0.5 ng/ml) until (after week 3), 2 consecutive, increasing T levels above castration level, with the latter one above 2ng/ml have been recorded. -To assess the effects on Luteinising Hormone (LH) -To assess the effects on Prostate Specific Antigen (PSA) -To assess the safety of Teverelix LA in terms of local tolerability and systemic tolerability (adverse events and changes in laboratory parameters);Primary end point(s): Duration of castration (ie T < 0.5 ng/ml) Escape from castration is defined as, after week 3, two consecutive increasing T levels above castration level, have been recorded, with the latter one above 2ng/ml.

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Countries

Latvia, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026