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

NCT02651987 | Completed Phase 2 Results DMC

• 2 other identifiers: 8-79-52030-3262014-005607-24
• Study Type: interventional
• Target: 99
• Locations: 10 countries
• Sites: 32

Brief 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.

Conditions

Pancreatic Tumours; Midgut Neuroendocrine Tumours

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival (PFS)

  PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.

  From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

Secondary Outcomes (16)

• Median Time to Progression

  From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

• Percentage of Subjects Alive and Progression Free

  Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)

• Overall Survival

  From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

• Objective Response Rate (ORR)

  Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)

• Disease Control Rate (DCR)

  Weeks 24 and 48

Study Arms (1)

Lanreotide Autogel®

EXPERIMENTAL

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

Drug: Lanreotide autogel 120 mg

Interventions

Lanreotide autogel 120 mg DRUG

Lanreotide Autogel®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (32)

Erasme Hospital

Brussels, 1070, Belgium

Location

Cliniques Unversitaires Saint Luc

Brussels, 1200, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, B-3000, Belgium

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charité - CVK

Berlin, 13353, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 69120, Germany

Location

St Vincent's University Hospital

Dublin, D4, Ireland

Location

IRCCS Azienda Ospedaliera Universitaria

San Martino, Genova, 16132, Italy

Location

Azienda Ospedaliera - Universitaria Careggi

Florence, 50134, Italy

Location

Fondacione IRCCS Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Università degli Studi "Federico II" di Napoli

Napoli, 80131, Italy

Location

Azienda Ospedaliera sant'Andrea

Roma, 00189, Italy

Location

AVL/NKI Medisch Oncologie

Amsterdam, 1066, Netherlands

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

Erasmus MC

Rotterdam, 3015, Netherlands

Location

Samodzielny Publiczny Szpital Kliniczny nr 5

Katowice, 40-952, Poland

Location

Katedra i Klinika Endokrynologii

Poznan, 60-355, Poland

Location

Centrum Diagnostyczno-Lecznicze "GAMMED"

Warsaw, 02-348, Poland

Location

Hospital Universitario Vall D'hebron

Barcelona, 08034, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Queen Elizabeth Medical Center

Birmingham, B15 2TH, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

The Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: January 11, 2016
• Study Start: December 15, 2015
• Primary Completion: October 16, 2019
• Study Completion: October 24, 2019
• Last Updated: October 3, 2022
• Results First Posted: December 30, 2020

Record last verified: 2022-09

Locations

IE (1); DK (2); NL (3); GB (3); IT (5); DE (3); ES (4); BE (4); FR (4); PL (3)