To assess efficacy&safety of BIM23A760 in Carcinoid Syndrome patients

• Research type

  Research Study

• Full title

  Phase II, open, adaptive, dose escalating, multicentre titration study to assess the efficacy and safety of repeated subcutaneous administration of different doses of BIM 23A760 in patients with carcinoid syndrome

• IRAS ID

  31229

• Contact name

  a b grossman

• Sponsor organisation

  Ipsen Pharma

• Eudract number

  2009-013222-16

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Neuroendocrine tumours (NETs) occur in endocrine glands, endocrine islets, as well as endocrine cells distributed within exocrine cells throughout the gastrointestinal (GI) and respiratory tracts. NETs of the gastroenteropancreatic (the unity of the gut and the pancreas) (GEP) system are rare (about 2% of all GI tumours), although incidence and occurrence have been increasing in the last two decades; the global clinical incidence is estimated to be around 2.5 to 5 cases/100000 per year, and prevalence is estimated to be around 25/100000If possible, radical surgery is the therapy of choice for primitive GEP NETs. If there are loco-regional or liver metastases, de-bulking surgery can also be performed.Somatostatin analogues allow control of hormone related symptoms. While these drugs effectively control symptoms and have a well established safety profile, there is a development of resistance in more than half of the patients in long term treatment; the mechanism of such resistance still needs to be explained. The objective of the clinical development plan is to demonstrate that BIM 23A760, a new chemical entity with a mode of action of combined SST analogue and Dopamine Agonist activities, has superior efficacy to current treatments for controlling symptoms in carcinoid tumours.It is estimated that approximately 60 patients will be enrolled and patients are expected to participate for approximately 29 weeks.The study consists of a screening visit, a baseline visit, 8 treatment period visits, and a final study visit during which patients will receive weekly injections of BIM 23A760. Assessments will be performed at each visit. Each patient will have 11 study visits.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/22

• Date of REC Opinion

  16 Jun 2010

• REC opinion

  Further Information Favourable Opinion