Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg

• Status: Completed
• Trial end date: 2019-10-24
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.

• Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.