E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
non functioning entero pancreatic neuro endocrine tumours |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052399 |
E.1.2 | Term | Neuroendocrine tumour |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to assess the long term safety of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero pancreatic neuro endocrine tumours. |
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E.2.2 | Secondary objectives of the trial |
to assess the long term efficacy of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning enteropancreatic neuro endocrine tumours. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Has provided written informed consent prior to any study-related procedures. 2) Has been enrolled and treated in Study 2-55-52030-726 and either: - Was stable at 96 weeks of treatment (whatever the treatment received during the two years of participation i.e no code break at Week 96). or - Has received at least one injection in Study 2-55-52030-726 and had a disease progression, confirmed by central assessment, during the course of the study and code break showed a placebo arm. 3) Has a World Health Organisation (WHO) performance score lower than or equal to 2. |
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E.4 | Principal exclusion criteria |
1) Has been enrolled and treated in the frame of the 2-55-52030- 726 protocol and had a disease progression during the study and the code break showed a treatment with lanreotide Autogel 120mg. 2) Has received any new treatment for the entero pancreatic neuro endocrine tumour since the end of participation in the 2-55- 52030-726 study. 3) Is likely to require any additional concomitant treatment to lanreotide Autogel 120mg for the entero pancreatic neuroendocrine tumour. 4) Has been treated with radionuclide at any time prior to study entry 5) Has a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120mg. 6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. 7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study. 8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patients safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10) Has been previously enrolled in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary criterion for the assessment of safety will be an investigation into the incidence of adverse events. The other safety endpoints are: Vital signs. Physical examination. ECG. Gallbladder echography. Laboratory tests: standard haematology and biochemistry. Concomitant medication. |
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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 | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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l`ultima visita dell`ultimo paziente in studio |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |