Non functioning entero-pancreatic tumour MedDRA version: 8.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour
Conditions
Interventions
Trade Name: SOMATULINE L.P. 120mg, solution injectable à libération prolongée en seringue préremplie
Product Name: Lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed
Sponsors
IPSEN Research and Development, BEAUFOUR IPSEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must fulfil the following: - Has provided written informed consent prior to any study-related procedures. - Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and either: ? Was stable at 96 weeks of treatment (whatever the treatment received during the two years of participation i.e no code break at Week 96). or ? Has received at least one injection in the frame of the 2-55-52030-726 protocol and had a disease progression, confirmed by central assessment, during the course of the study and code break showed a placebo arm. - Has a World Health Organisation (WHO) performance score lower or equal to 2. 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
Exclusion criteria
Exclusion criteria: Patients will not be included in the study if the patient : - Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and had a disease progression during the study and the code break showed a treatment with lanreotide Autogel 120mg. - Has received any new treatment for the entero pancreatic neuro endocrine tumour since the end of participation in the 2-55-52030-726 study. - Is likely to require any additional concomitant treatment to the lanreotide Autogel 120mg for the entero-pancreatic neuro endocrine tumour. - Has been treated with radionuclide at any time prior to study entry. - Has a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120mg. - 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 the start of study 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 3 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 findings at visit 1, 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. - Has been previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the long term safety of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero-pancreatic neuro endocrine tumour.;Secondary Objective: The secondery objective is to assess the long term efficacy of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero-pancreatic neuro endocrine tumour.;Primary end point(s): The primary criterion for the assessment of safety will be an investigation into the incidence of adverse events. The other safety endpoints are: • Vital signs • Physical examination • ECG • Gallbladder echography • Laboratory tests: standard haematology and biochemistry • Concomitant medication | — |
Countries
Belgium, Czech Republic, France, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed