Phase III, randomised, double-blind, stratified comparative, placebo controlled, parallel group, multicentre study to assess the effect of deep subcutaneous injections of lanreotide Autogel 120 mg administered every 28 days on tumour progression free survival in patients with non functioning entero-pancreatic endocrine tumour. - Not applicable
- Conditions
- on functioning entero-pancreatic tumoursMedDRA version: 8.1Level: PTClassification code 10052399Term: Neuroendocrine tumour
- Registration Number
- EUCTR2005-004904-35-NL
- Lead Sponsor
- IPSEN Research and Development, BEAUFOUR IPSEN PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
- Provision of written informed consent prior to any study related procedures,
- Male or female of 18 years of age or older,
- Has an endocrine tumour confirmed by centrally assessed histological criteria.
- Has a metastatic disease and/or an locally advanced inoperable tumour, or the patient has refused surgery (documented).
- Has a tumour measurable according to RECIST criteria (central assessment),
- Has no hormone related symptoms,
- Has a non-functioning entero-pancreatic tumour of unknown origin; or with a known primary localisation in the pancreas, mid-gut or hint gut, or a gastrinoma adequately controlled by proton-pump inhibitors (4 months stable prior to study entry).
- Has a well or moderately differentiated tumour (central assessment)
- Has a tumour with proliferation index (Ki67) < 10 % or, in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index = 2 mitosis/10 HPF (central assessment),
- 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
- Has a World Health Organisation (WHO) performance score lower or equal to 2
- Has had a biopsy performed within 6 months prior to the screening visit if the patient has had a previous cancer or, if in the opinion of the investigator, there is evidence of clinical progression.
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
- 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),
- Has been treated with a radionuclide at any time prior to study entry (Visit 1),
- Has been treated with interferon, chemoembolisation or chemotherapy within 6 months prior to study entry (Visit 1),
- 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 intent and free from disease for more than 5 years),
- Has a history of hypersensitivity to drugs with a similar chemical structure
- Has been treated with any otherbunlicensed drug within the last 30 days before study entry (visit 1)
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol
- 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-menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- 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
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patient's safety or decrease the chnace of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Has been previously enrolled in this study
- Has had major surgery related to the studied disease within 3 months prior to entering the study.
- Has a multiple endocrine neoplasia (MEN).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method