Study to assess the effect of lanreotide Autogel 120 mg compared to placebo on tumour progression free survival in patients with a certain endocrine digestive tumour.
- Conditions
- MedDRA version: 14.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]on functioning entero-pancreatic tumours
- Registration Number
- EUCTR2005-004904-35-BE
- Lead Sponsor
- Ipsen Pharma S.A.S.
- 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 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 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93
- 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),
- 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 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