Non functioning entero-pancreatic tumours MedDRA version: 14.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SOMATULINE AUTOGEL 120 mg
Product Name: Lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotid
Sponsors
IPSEN PHARMA S.A.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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) =65 years) yes F.1.3.1 Number of subjects for this age range 93
Exclusion criteria
Exclusion criteria: - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be time to either disease progression (measured using RECIST criteria) or death, within 96 weeks after first study treatment administration.;Timepoint(s) of evaluation of this end point: The primary endpoint will be time to either disease progression (measured using RECIST criteria) or death, within 96 weeks after first study treatment administration.;Main Objective: The main objective is 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 tumour.; Secondary Objective: Compare the proportion of patients without progression between both groups at 48 and 96 weeks Compare time to progression in patients with progression between both groups Assess OS in this patient population Assess the effect of lanreotide Autogel120mg compared to placebo on quality of life using EORTC QLQ-C30 and QLQ-GI.NET21 questionnaires Assess the effect of lanreotide Autogel120mg compared to placebo on plasma chromogranin A and on any other tumour peptide markers with elevated level at baseline and week 48 (Visit 2) Assess the clinical and biological safety profile of lanreotide Autogel120mg Assess the putative appearance of lanreotide antibodies Assess the pharmacokinetic profile of lanreotide Autogel 120 mg In addition characterization of tumour somatostatin receptors profile may also be assessed. This will be proposed to all patients on an optional basis (i.e. each patient will have the opportunity to consent or not on this specific assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Please see section E.5.2; Secondary end point(s): Porportion of patients without progression or death in each treatment group at 48 and 96 weeks Time to progress in each treatment group Overall survival defined as the time from first study treatment administration to death due to any cause Quality of life using EORTC, QLQ-C30 and QLQ-GI.NET21 at baseline and weeks 12, 24, 36, 48, 72 and 96 Plasma chromogranin A level at baseline and weeks 12, 24, 36, 48, 60, 72, 84 and 96 Tumour markers (pancreatic polypeptide, gastrin, VIP, glucagon, somatostatin, insulin, neurotensin and urinary 5-HIAA) levels at baseline and weeks 48 and 96. In addition, any tumour marker above normal range at baseline will be assessed at weeks 12, 24, 36, 60, 72 and 84 and any tumour marker above normal range at week 48 will be assessed at weeks 60, 72 and 84 AE information will be recorded for each patient throughout the study Vital signs, physical examination at each study visit from screening to study completion ECG at baseline, week 48 and week 96 Gall bladder echography at baseline, week 48 and 96 Laboratory tests: standard haematology and biochemistry analysis at screening, baseline, week 48 and 96 Appearance of putative anti-lanreotide antibodies at baseline, week 24, week 48, week 72 and week 96 Lanreotide serum concentration at baseline and weeks 4, 12, 24, 36, 48, 72 and 96 (Cw4, Cw12, Cw24, Cw36, Cw48, Cw72 and Cw96 respectively) Pharmacokinetic profile after the 1st and 6th administrations. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactAnne Verny
Ipsen Pharma S.A. S
Outcome results
None listed