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

Ipsen

Status and phase: Completed; Phase 2

Conditions: Midgut Neuroendocrine Tumours; Pancreatic Tumours

Treatments: Drug: Lanreotide autogel 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02651987

8-79-52030-326

2014-005607-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Lanreotide Autogel®

Experimental group

Description:

One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.

Treatment:

Drug: Lanreotide autogel 120 mg