CLARINET FORTE Final Version: 19 May 2015
Research type
Research Study
Full title
EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL® 120 MG ADMINISTERED EVERY 14 DAYS IN WELL DIFFERENTIATED, METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE PANCREATIC OR MIDGUT NEUROENDOCRINE TUMOURS HAVING PROGRESSED RADIOLOGICALLY WHILE PREVIOUSLY TREATED WITH LANREOTIDE AUTOGEL® 120 MG ADMINISTERED EVERY 28 DAYS
IRAS ID
186202
Contact name
Christos Toumpanakis
Contact email
Sponsor organisation
Ipsen Innovation
Eudract number
2014-005607-24
Duration of Study in the UK
4 years, 1 months, 0 days
Research summary
This is a clinical trial to explore the efficacy and safety of a reduced lanreotide Autogel® dosing interval (120 mg every 14 days) in subjects with grade 1 or 2 (according to WHO 2010 classification), metastatic or locally advanced unresectable Pancreatic Neuroendocrine tumor (pNETs) or Midgut Neuroendocrine tumour (NETs) once they have progressed on the standard dose of lanreotide Autogel® (120 mg every 28 days).
Neuroendocrine tumours (NETs) are a heterogeneous and rare group of malignancies originating from neural crest cells, endocrine glands, endocrine islets or in the diffuse neuroendocrine system. Although NETs may develop in almost any organ, they predominate within the pancreas and the gastrointestinal (GI) tract.The study drug, lanreotide Autogel, is a manmade form of a natural hormone called somatostatin. Lanreotide Autogel® 120 mg every 28 days is used for the treatment and control of the growth of some advanced tumors of the intestine and the pancreas called gastroenteropancreatic neuroendocrine tumors or GEP-NETS.
Previous research studies have shown that lanreotide and similar drugs may decrease and stabilise the size of tumours. They also showed the activity of Lanreotide Autogel® 120 mg every 28 days on tumour control and their positive effect relief of clinical symptoms.
Currently, patients with progressive disease after treatment with lanreotide Autogel® (120 mg every 28 days) have limited treatment options and receive aggressive and less tolerated systemic chemotherapy or molecular targeted therapies, such as everolimus or sunitinib. As lanreotide has a favourable tolerability profile, a reduced dosing interval might delay the need for such therapies and could potentially improve a patient's quality of life.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0682
Date of REC Opinion
17 Feb 2016
REC opinion
Further Information Favourable Opinion