E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced and/or metastatic prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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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 long-term safety of Teverelix LA in terms of local and systemic tolerability (adverse events and changes in laboratory parameters) |
|
E.2.2 | Secondary objectives of the trial |
•To assess the long-term efficacy of Teverelix LA in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml) up to 32 weeks •To assess the effects on Prostate Specific Antigen (PSA) •To assess the effects on Luteinizing Hormone (LH)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Per protocol completion of study no. ARD-0301-004 •Prostate cancer assessed by the clinical investigator as being adequately controlled by 4-weekly subcutaneous administration of 90 mg Teverelix LA •Suitable androgen deprivation therapy (advanced prostate cancer i.e. with local invasion and/or metastasis) •Signed, written informed consent
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E.4 | Principal exclusion criteria |
•Testosterone > 2 ng/ml at Week 24 visit of ARD-0301-004 study •Increasing PSA levels at Week 24 visit of ARD-0301-004 study •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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
maintenance of castration (testosterone < 0.5 ng/ml) until Week 28 |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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
|
Last visit of the last subject undergoing the trial |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |