NCT02288377: REMINET

A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT

Terminated Phase 2/Phase 3 Results posted Last updated 21 December 2022

What this trial tests

Phase 2/Phase 3 trial testing lanreotide in Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours in 53 participants. Terminated before completion.

Timeline

1 January 2015

Primary endpoint
1 January 2020

1 January 2020

Quick facts

Lead sponsor	Federation Francophone de Cancerologie Digestive
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	53
Start date	1 January 2015
Primary completion	1 January 2020
Estimated completion	1 January 2020
Sites	24 locations across Belgium, France, Germany, United Kingdom

Drugs / interventions tested

• lanreotide (LANREOTIDE) — full drug profile →
• Placebo

Conditions studied

• Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours — all drugs for Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours →

Sponsor

Federation Francophone de Cancerologie Digestive — full company profile →

Who can join

18 and older, any sex, with Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of Patients Alive and Progression-free at 6 Months
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Antiproliferative Role of Lanreotide in Controlling Growth of Neuroendocrine Tumors: A Systematic Review.
   Michael M, Garcia-Carbonero R, Weber MM, Lombard-Bohas C, et al · · 2017 · cited 20× · PMID 28220021 · DOI 10.1634/theoncologist.2016-0305
2. Systemic Treatment Selection for Patients with Advanced Pancreatic Neuroendocrine Tumours (PanNETs).
   Megdanova-Chipeva VG, Lamarca A, Backen A, McNamara MG, et al · · 2020 · cited 19× · PMID 32708210 · DOI 10.3390/cancers12071988
3. 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.
   Lepage C, Phelip JM, Lievre A, Le-Malicot K, et al · · 2022 · cited 18× · PMID 36087395 · DOI 10.1016/j.ejca.2022.07.033
4. Systematic Review of the Role of Targeted Therapy in Metastatic Neuroendocrine Tumors.
   Lee A, Chan DL, Wong MH, Li BT, et al · · 2017 · cited 10× · PMID 27082107 · DOI 10.1159/000446115
5. Clinical and Preclinical Advances in Gastroenteropancreatic Neuroendocrine Tumor Therapy.
   Crabtree JS. · · 2017 · cited 9× · PMID 29255447 · DOI 10.3389/fendo.2017.00341
6. "Cold" Somatostatin Analogs in Neuroendocrine Neoplasms: Decoding Mechanisms, Overcoming Resistance, and Shaping the Future of Therapy.
   Massironi S, Albertelli M, Hasballa I, Paravani P, et al · · 2025 · cited 7× · PMID 39996718 · DOI 10.3390/cells14040245
7. Medical Management of Gastroenteropancreatic Neuroendocrine Tumors.
   Chandrasekharan C. · · 2020 · cited 7× · PMID 32151362 · DOI 10.1016/j.soc.2019.11.004
8. An Overview on the Sequential Treatment of Pancreatic Neuroendocrine Tumors (pNETs).
   Alonso-Gordoa T, Díez JJ, Molina J, Reguera P, et al · · 2015 · cited 4× · PMID 27182476 · DOI 10.1007/s40487-015-0007-6