Open-label study of Lanreotide Autogel in entero-pancreatic tumours

• Research type

  Research Study

• Full title

  OPEN LABEL EXTENSION STUDY OF LANREOTIDE AUTOGEL 120 MG IN PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR

• IRAS ID

  11609

• Sponsor organisation

  Ipsen Pharma SAS

• Eudract number

  2008-004019-36

• ISRCTN Number

  Not Known

• Research summary

  This a multicentre, open label extension study of lanreotide Autogel 120mg in patients with non functioning entero-pancreatic endocrine tumour.Endocrine tumours are a rare group of tumours with an increasing incidence,Endocrine tumours arise from endocrine cells and are usually located in the gastrointestinal (GI) tract (90%) but are also seen in the pancreas and pulmonary bronchii.Initial treatment consists of surgical removal of the tumour when possible, andtreatment of hormonal syndrome when present. Once the tumour enters into a progressive phase, treatment usually includes, chemotherapy, surgery and radiotherapy. Response rate of these treatments depends on tumour type, and they are often associated with frequent and severe side effects. However, none of these therapies has been demonstrated to result in a significant prolongation of survival. Somatostatin analogues are the treatment of choice for hormone-related syndromes,and lanreotide Autogel is registered for the treatment of symptoms associated withcarcinoid tumours in over 50 countries worldwide. Lanreotide Autogel is a prolonged release, pharmaceutical form of lanreotide. The Autogel formulation has been developed for two main reasons. Firstly, its characteristics of a smoother and more extended release of lanreotide permit injection interval of 28 days. Secondly, the formulation has the advantage of providing a ready to use deep subcutaneous injection.While somatostatin analogue treatment is the primary medical therapy for patients with symptoms related to gastroenteropancreatic neuroendocrine tumours, there is no currently a reference standard medical therapy for asymptomatic patients.It is expected that the study 2-55-52030-726 (currently ongoing) will provide this information. Pending these results, therapy with somatostatin analogues remains a proposed option to patients with stable disease enabling investigators to have the possibility to enrol their patients with stable disease after completion of the initial study. Only patients having participate in a previous protocol (study 2-55-52030-726) will be eligible to be enrolled in this extension study.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/37

• Date of REC Opinion

  8 Jun 2009

• REC opinion

  Further Information Favourable Opinion