NCT00842348: NET729

Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Completed Phase 3 Results posted Last updated 15 September 2022

What this trial tests

Phase 3 trial testing lanreotide (Autogel formulation) in Non Functioning Entero-pancreatic Endocrine Tumour in 89 participants. Completed in 1 December 2015.

Timeline

1 February 2009

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Ipsen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	1 February 2009
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	25 locations across United States, Belgium, Czechia, France, Italy, Poland, Slovakia, Spain

Drugs / interventions tested

• lanreotide (Autogel formulation) — full drug profile →

Conditions studied

• Non Functioning Entero-pancreatic Endocrine Tumour — all drugs for Non Functioning Entero-pancreatic Endocrine Tumour →

Sponsor

Ipsen — full company profile →

Who can join

18 and older, any sex, with Non Functioning Entero-pancreatic Endocrine Tumour. 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.

• Adverse Events
  Time frame: Throughout the study until the completion/early discontinuation visit.
  Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were r

Sponsor's own description

The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).

Publications & conference data

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

1. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study.
   Caplin ME, Pavel M, Ćwikła JB, Phan AT, et al · · 2016 · cited 164× · PMID 26743120 · DOI 10.1530/erc-15-0490
2. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.
   Caplin ME, Pavel M, Phan AT, Ćwikła JB, et al · · 2021 · cited 59× · PMID 33052555 · DOI 10.1007/s12020-020-02475-2
3. Gastroenteropancreatic neuroendocrine neoplasms: current development, challenges, and clinical perspectives.
   Zhang XB, Fan YB, Jing R, Getu MA, et al · · 2024 · cited 24× · PMID 38835066 · DOI 10.1186/s40779-024-00535-6
4. Medical treatment for gastro-entero-pancreatic neuroendocrine tumours.
   Berardi R, Morgese F, Torniai M, Savini A, et al · · 2016 · cited 15× · PMID 27096034 · DOI 10.4251/wjgo.v8.i4.389
5. Emerging innovations in theranostics for pancreatic neuroendocrine tumors.
   Karimi A, Bogdani C, O'Dwyer E, Siolas D. · · 2025 · cited 8× · PMID 40389624 · DOI 10.1038/s41698-025-00938-1
6. An Update on Novel Pharmacotherapies for the Treatment of Neuroendocrine Tumors.
   Choucair K, Odabashian R, Reddy SN, Azmi AS, et al · · 2025 · PMID 41303577 · DOI 10.3390/ijms262211095