GTE – Groupes d'étude des tumeurs endocrines

Type d'étude :: Phase II
Promoteur :: IPSEN
Etat actuel de l'étude :: Clos aux inclusions sauf la cohorte pancréas (qq patients)

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.

Code de l’étude

CLARINET Forte

Promoteur/ sponsor

IPSEN

Tumeur éligible

TNE gastroenteropancréatique

Type d’étude

Interventionnelle : Somatuline Autogel® 120 mg administered every 14 days

Phase

Open label, single arm, non-comparative, multicentre study

Nombre de patients à inclure

100 patients (50 midgut, 50 pancréas)

Investigateur(s) principal

Pr. Ruszniewski (Clichy)

Centres Français

Lyon, Marseille, Clichy, Villejuif

Objectifs

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)

Critères d’inclusion

–   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

Critères d’exclusion

•   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

CLARINET FORTE