Health Condition 1: null- Non functioning entero-pancreatic endocrine tumour
Conditions
Interventions
Intervention1: Lanreotide Autogel: 120 mg administered every 28 days
Control Intervention1: Placebo: administered every 28 day
Sponsors
IPSEN PHARMA SAS
Eligibility
Inclusion criteria
Inclusion criteria: All patients will be included if the following criteria are fulfilled: (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 endocrine tumour confirmed by centrally assessed histological criteria, (4) Has metastatic disease and/or locally advanced inoperable tumour, or the patient has refused surgery (documented), (5) Has a tumour measurable according to RECIST criteria (central assessment), (6) Has no hormone related symptoms, (7) Has a non functioning entero-pancreatic tumour of unknown origin; or with a known primary localization in the pancreas, mid-gut, or hindgut, or a gastrinoma adequately controlled by proton-pump inhibitors (4 months stable prior to study entry), (8) Has a well or moderately differentiated tumour (central assessment), (9) Has a tumour with a proliferation index (Ki67) (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 (12) 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.
Exclusion criteria
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, chemobolisation 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 intent 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-menopausal for at least 1 year, surgical sterilization or hysterectomy at least 3 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?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, (12) Has had major surgery related to the studied disease within 3 months prior to entering the study, (13) Has a multiple endocrine neoplasia (MEN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Lanreotide Autogel 120 mg administered every 28 days compared to placebo, on progression-free survival in patients with well or moderately differentiated non functioning entero-pancreatic endocrine tumours. The primary endpoint will be time to either disease progression (measured using RECIST criteria) or death, occurring within 96 weeks after first treatment administration.Timepoint: 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To compare the proportion of patients alive and without progression both groups at 48 and 96 weeks,? To compare time to progression in patients with progression between groups,Timepoint: At 48 and 96 weeks | — |
Countries
Czech Republic, India, Italy, Poland, Slovakia, Spain, United Kingdom
Contacts
Public ContactSanjay Kabra
Pharmanet/i3
Outcome results
None listed