Clinical Trials

ELECT® (A doublE-bLind, randomizEd placebo controlled Clinical Trial investigating the efficacy and safety of Somatuline® (lanreotide) injection in the treatment of carcinoid syndrome) is a 48-week Phase III trial in patients with a history of carcinoid syndrome. The study consisted of a 16-week, double-blind, randomized (to either Somatuline® of placebo), placebo-controlled phase followed by a 32-week open-label phase. Throughout the study the patients were allowed to use rescue medication in the form of subcutaneous somatostatin analogues (octreotide) as needed to control their symptoms related to carcinoid syndrome. The primary endpoint was the percentage of days subcutaneous octreotide was required to control symptoms associated with carcinoid syndrome, as rescue medication during the 16-week double-blind phase of the study. Secondary endpoints included frequency of diarrhea and flushing, usage of other rescue medication, Quality of Life, tumor markers and safety. (NCT00774930).

* On September 17, 2013, Ipsen has announced positive top line results from the primary endpoint of the ELECT® study, assessing the effect of Somatuline® Autogel® / Somatuline Depot® (lanreotide) Injection 120 mg (referred to as Somatuline®) on the control of symptoms in patients with neuroendocrine tumors (NETs) associated with carcinoidsyndrome. Treatment with Somatuline® was found to be statistically significantly superior to placebo in decreasing the number of days patients needed to use rescue medication (subcutaneous somatostatin analogues i.e., octreotide) to control symptoms associated with carcinoid syndrome. The safety profile observed in the study is consistent with the known safety profile of Somatuline®. Ipsen expects to present comprehensive results from this study at the 2014 Gastrointestinal Cancers Symposium (January 16-18, 2014 in San Francisco, CA). Somatuline® is approved for the treatment of symptoms associated with carcinoid syndrome in neuroendocrine tumors in many international markets where it is marketed as Somatuline® Autogel®, but not in the US, where it is marketed as Somatuline® Depot. As such, data arising from the ELECT® study can be considered as an investigational use of Somatuline Depot in the United States.