Health Condition 1: null- Non functioning entero-pancreatic endocrine tumour
Conditions
Interventions
Intervention1: Lanreotide Autogel 120 mg
: Lanreotide Autogel is presented as dose strength 120 mg. The proportion of peptide and excipient (water for injection) is 0.246 mg/mg.
The treatment will be
Sponsors
IPSEN PHARMA SAS
inVentiv International Pharma Services Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: All patients must fulfil the following: 1) Has provided written informed consent prior to any study-related procedures. 2) Has been enrolled and treated in Study 2-55-52030-726 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 Study 2-55-52030-726 and had a disease progression, confirmed by central assessment, during the course of the study and code break showed a placebo arm. 3) Has a World Health Organisation (WHO) performance score lower than or equal to 2.
Exclusion criteria
Exclusion criteria: Patients will not be included in the study if the patient : 1) 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. 2) Has received any new treatment for the entero pancreatic neuroendocrine tumour since the end of participation in the 2-55-52030-726 study. 3) Is likely to require any additional concomitant treatment to lanreotide Autogel 120mg for the entero pancreatic neuroendocrine tumour. 4) Has been treated with radionuclide at any time prior to study entry. 5) Has a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg. 6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. 7) Is at risk of pregnancy or lactation. 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-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study. 8) 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. 9) Has abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patientâ??s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10) Has been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| long term safety of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero pancreatic neuroendocrine tumour.Timepoint: 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| the long term efficacy of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero pancreatic neuroendocrine tumours.Timepoint: 96 weeks | — |
Countries
Czech Republic, India, Italy, Poland, Slovakia, Spain, United Kingdom
Contacts
Public ContactSanjay Kabra
Pharmanet/i3
Outcome results
None listed