E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the duration of action of an initial "loading" dose regimen of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml) |
|
E.2.2 | Secondary objectives of the trial |
- To assess the pharmacodynamics of teverelix in terms of ability to suppress and to 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 2 ng/ml, have been recorded - To assess the effects on Luteinizing 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) |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
|
|
E.4 | Principal 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 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Suppression of testosterone to castrate level (0.5 ng/ml) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last subject he last visit: subjects will be followed up until, after week 3, two consecutive, increasing T levels above castration level, have been recorded, with the latter one above 2 ng/ml |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |