The efficacy of Somatuline Depot was tested in a phase III, 96-week, international, randomized, double-blind, placebo-controlled trial called CLARINET.1,2†
The efficacy of Somatuline Depot was studied in 204 patients with unresectable, well- or moderately-differentiated, metastatic or locally advanced, gastroenteropancreatic neuroendocrine tumors. Patients were required to have nonfunctioning tumors without hormone-related symptoms.1
For additional information about the study methodology, please see Study Design and Patient Information below.
Most common adverse reactions (greater than 10%) are abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.1 Please see Adverse Reactions below for more information about these possible side effects. Please tap or click here to review the full Important Safety Information for Somatuline Depot.
*GEP-NETs=gastroenteropancreatic neuroendocrine tumors. †CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors.
*CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors. †Administered every 28 days by deep subcutaneous injection. Follow-up visits occurred at Weeks 12, 24, 36, 48, 72, 96. ‡Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
CLARINET included patients with unresectable, well- to moderately-differentiated, locally advanced or metastatic GEP-NETs, a range of hepatic tumor loads, and varying primary tumor locations (foregut/pancreas, midgut, or hindgut).1,2
Baseline prognostic characteristics were similar between arms with one exception: There were 39% of patients in the Somatuline Depot arm and 27% of patients in the placebo arm who had hepatic involvement by tumor of >25%.1
aIncludes preferred terms of abdominal pain, abdominal pain upper/lower, abdominal discomfort. bIncludes preferred terms of myalgia, musculoskeletal discomfort, musculoskeletal pain, back pain. cIncludes preferred terms of infusion site extravasation, injection site discomfort, injection site granuloma, injection site hematoma, injection site hemorrhage, injection site induration, injection site mass, injection site nodule, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling. dIncludes preferred terms of diabetes mellitus, glucose tolerance impaired, hyperglycemia, type 2 diabetes mellitus. eIncludes preferred terms of hypertension, hypertensive crisis. fIncludes preferred terms of depression, depressed mood. *Includes one or more serious adverse events (SAEs) defined as any event that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability, results in congenital anomaly/birth defect, or may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed. †Defined as hazardous to well-being, significant impairment of function or incapacitation.
Somatuline Depot is FDA-approved to treat adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
The most common adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in greater than 5% of patients who received Somatuline Depot in the carcinoid syndrome trial and occurring at least 5% greater than placebo were headache (12%), dizziness (7%), and muscle spasm (5%).
OL=open-label; OLE=open-label extension. Primary endpoint: Percentage of days with use of rescue octreotide acetate (surrogate efficacy endpoint).
The patient population had a mean age of 59 years (range, 27-85 years); 58% were female and 77% were Caucasian.1
Fifty-six percent of patients had received octreotide prior to randomization, and 84% of patients experienced moderate or severe diarrhea or flushing at baseline.1Key inclusion criteria were positive somatostatin receptor status and absence of tumor progression. Key exclusion criteria included3:
*ELECT=Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment.
*Baseline symptoms assessed during screening phase. DB=double-blind; ITT=intention-to-treat; SD=standard deviation; LAN=lanreotide autogel/depot.
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