A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

NCT02288377 | Terminated Phase 2 Results DMC

• 1 other identifier: PRODIGE31
• Study Type: interventional
• Target: 53
• Locations: 4 countries
• Sites: 24

Brief Summary

This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

Conditions

Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours

Keywords

Lanreotide; Duodeno-pancreatic neuroendocrine tumours; Maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Alive and Progression-free at 6 Months

  The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.

  6 months

Secondary Outcomes (2)

• Progression-Free Survival

  up to 2 years

• Overall Survival

  2 years after the end of the treatment

Study Arms (2)

lanreotide

EXPERIMENTAL

In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression

Drug: lanreotide

placebo

PLACEBO COMPARATOR

In this arm, patients will receive placebo every 28 days until disease progression

Drug: Placebo

Interventions

lanreotide DRUG

Patients will receive lanreotide 120 mg every 28 days until disease progression

lanreotide

Placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
• Progressive before first-line treatment
• Histologically confirmed (either on primary tumour or metastases)
• Pathological diagnosis validated by the NET consulting pathologist
• Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
• The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
• Non-functional tumour or gastrinoma controlled by PPIs
• Age \> or = 18 years
• WHO 0, 1 or 2
• Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
• Signed informed consent prior to initiation of any study-specific procedures or treatment.

You may not qualify if:

• History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
• Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 \> 20%)
• If primary resected, bone metastasis exclusively
• Pre-treatment by somatostatin long-acting analogue
• Total bilirubin ≥ 60 µmol/L
• Uncontrolled diabetes
• Contraindication to product used in the study or its components
• Tumour arising in the context of a genetic disease
• Pregnancy or lactation
• Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
• Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (24)

Clinique Universitaire saint-Luc

Brussels, Belgium

Location

CHU d'Angers - Hôtel Dieu

Angers, France

Location

CHU - Hôpital Avicenne

Bobigny, France

Location

CHU Côte de Nacre

Caen, France

Location

CHU Estaing

Clermont-Ferrand, France

Location

Hôpital Beaujon

Clichy, France

Location

CHU Le Bocage Service d'HGE

Dijon, 21079, France

Location

CH Les Oudairies

La Roche-sur-Yon, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

CHU La Timone

Marseille, France

Location

Hôpital de la Source

Orléans, France

Location

CHU Cochin

Paris, France

Location

Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie

Pessac, France

Location

Hôpital de la Milétrie

Poitiers, France

Location

Hôpital Robert Debré

Reims, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

Location

CHU Charles Nicolle

Rouen, France

Location

CHU de Saint Etienne

Saint-Priest-en-Jarez, France

Location

Hôpital Rangueil

Toulouse, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Charite Campus Virchow Kilikum

Berlin, Germany

Location

University Hospital Marburg

Marburg, Germany

Location

Royal Free Hospital Neuroendocrine Tumour Unit

London, United Kingdom

Location

Manchester Academic Health Sciences Centre (MAHSC)

Manchester, United Kingdom

Location

Related Publications (3)

• Lepage C, Dahan L, Bouarioua N, Toumpanakis C, Legoux JL, Le Malicot K, Guimbaud R, Smith D, Tougeron D, Lievre A, Cadiot G, Di Fiore F, Bouhier-Leporrier K, Hentic O, Faroux R, Pavel M, Borbath I, Valle JW, Rinke A, Scoazec JY, Ducreux M, Walter T. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.

  PMID: 28292641 BACKGROUND

• Guiney DG Jr, Hasegawa P, Davis CE. Homology between clindamycin resistance plasmids in Bacteroides. Plasmid. 1984 May;11(3):268-71. doi: 10.1016/0147-619x(84)90035-0.

  PMID: 6087395 RESULT

• Lepage C, Phelip JM, Lievre A, Le-Malicot K, Dahan L, Tougeron D, Toumpanakis C, Di-Fiore F, Lombard-Bohas C, Borbath I, Coriat R, Lecomte T, Guimbaud R, Petorin C, Legoux JL, Michel P, Scoazec JY, Smith D, Walter T. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study. Eur J Cancer. 2022 Nov;175:31-40. doi: 10.1016/j.ejca.2022.07.033. Epub 2022 Sep 7.

  PMID: 36087395 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karine Le Malicot
• Organization: FFCD

karine.le-malicot@u-bourgogne.fr

+ 33 3 80 39 34 79

Study Officials

• Come Lepage, Pr

  Federation Francophone de Cancerologie Digestive

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 18, 2023
• Results First Posted: October 4, 2021

Record last verified: 2022-12

Locations

FR (19); BE (1); GB (2); DE (2)