E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR |
|
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 | 10061121 |
E.1.2 | Term | Endocrine neoplasm |
|
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 |
The primary study objective is to assess the effect of lanreotide
Autogel 120mg administered every 28 days compared to placebo, on
progression-free survival in patients with well or moderately
differentiated non functioning entero-pancreatic endocrine tumour.
The primary endpoint will be time to either disease progression
(measured using RECIST criteria) or death, within 96 weeks after
first treatment administration. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
ユ To compare the proportion of patients alive and without
progression between both groups at 48 and 96 weeks,
ユ To compare time to progression in patients with progression between both groups,
ユ To assess the effect of lanreotide Autogel 120 mg compared to placebo on quality of life using EORTC QLQ-C30 and QLQGI.
NET21 questionnaires,
ユ To assess the effect of lanreotide Autogel 120 mg compared to placebo on plasma chromogranin A and on any other tumour peptide markers with elevated level at baseline (Visit 2),
ユ To assess the clinical and biological safety profile of lanreotide
Autogel 120 mg,
ユ To assess the putative appearance of lanreotide antibodies,
ユ To assess the pharmacokinetic profile of lanreotide Autogel 120 mg |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Has provided written informed consent prior to any study related procedures,
2) Is a male or a female of 18 years of age or older,
3) Has an entero-pancreatic endocrine tumour centrally confirmed by histological criteria,
4) Has metastatic disease and/or locally advanced inoperable tumour,
5) Has a tumour measurable according to RECIST criteria (central assessment),
6) Has no hormone related symptoms,
7) Has an entero-pancreatic endocrine tumour with the primary localisation in
pancreas, mid-gut or hind gut,
8) Has a well or moderately differentiated tumour (central assessment),
9) Has a tumour with proliferation index (Ki67) < 10% (central assessment),
10) Has a >= grade 2 octreoscan assessed using the Krenning scale, during the screening period or within 6 months prior to study entry (Visit 1) for the organ of target lesions,
11) Has a World Health Organisation (WHO) performance score lower or equal to 2 |
|
E.4 | Principal exclusion criteria |
Patient will not be included in the study if he/she :
1) Has been treated with a somatostatin analogue at any time prior to study entry(Visit 1), except if that treatment was for less than 15 days (e.g. peri-operatively)and the treatment was received more than 6 months before study entry (Visit 1),
2) Has been treated with radionuclide at any time prior to study entry (Visit 1),
3) Has been treated with interferon, chemoembolisation or chemotherapy within 6 months prior to study entry (Visit 1),
4) Has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intend and free from disease for more than 5 years),
5) Has a history of hypersensitivity to drugs with a similar chemical structure,
6) Has been treated with any other unlicensed drug within the last 30 days before study entry (Visit 1),
7) Is likely to require treatment during the study with drugs that are not permitted by the study protocol (see Section 9.6),
8) Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test at study entry (Visit 1) and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined
as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
9) 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,
10) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patientメs safety or decrease the chance of obtaining satisfactory data needed to achieve
the objective(s) of the study,
11) Has been previously enrolled in this study, |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary study objective is to assess the effect of lanreotide
Autogel 120mg administered every 28 days compared to placebo, on
progression-free survival in patients with well or moderately
differentiated non functioning entero-pancreatic endocrine tumour.
The primary endpoint will be time to either disease progression
(measured using RECIST criteria) or death, within 96 weeks after
first treatment administration. |
|
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 | No |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |