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Efficacy and safety of Somatuline Autogel® 120 mg administered every 14 days in well differentiated, metastatic or locally advanced, unresectable gastro-entero-pancreatic neuroendocrine tumours having progressed radiologically while previously treated with Somatuline Autogel® 120 mg administered every 28 days.
Open label, single arm, non-comparative, multicentre study.
Interventionnelle : Somatuline Autogel® 120 mg administered every 14 days
Open label, single arm, non-comparative, multicentre study
100 patients (50 midgut, 50 pancréas)
Pr. Ruszniewski (Clichy)
Lyon, Marseille, Clichy, Villejuif
Objectif principal : Progression Free Survival
Objectifs secondaires :
• To evaluate the clinical and biological safety profile.
• To evaluate time to progression.
• To evaluate PFS and survival rates every 12 weeks.
• To evaluate overall survival at 1 and 3 years.
• To evaluate the objective response rate as per RECIST 1.0.
• To detect predictive factors of PFS.
• To evaluate the effect on symptoms (diarrhoea, flushing) in symptomatic patients.
• To evaluate the changes in tumour biomarkers: chromogranin A, other tumour peptide markers with elevated level at baseline
* To evaluate the appearance of lanreotide antibodies.
• To evaluate the pharmacokinetic profile in relation to pharmacodynamics (PFS, tumour response or chromogranin A)
– Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ?20%.
– Positive somatostatin receptors type 2
– Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks
• Grade 3 or rapidly progressive (within 12 weeks) NET
• Any NET other than pancreatic and midgut
• Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days
• Gallbladder lithiasis at Screening echography or history of cholelithiasis with no cholecystectomy since then