NCT00353496: CLARINET

Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Completed Phase 3 Results posted Last updated 18 February 2025

What this trial tests

Phase 3 trial testing lanreotide (Autogel formulation) in Endocrine Tumors in 264 participants. Completed in 1 April 2013.

Timeline

1 June 2006

Primary endpoint
1 April 2013

1 April 2013

Quick facts

Lead sponsor	Ipsen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	264
Start date	1 June 2006
Primary completion	1 April 2013
Estimated completion	1 April 2013
Sites	71 locations across United States, Austria, Belgium, Czechia, Denmark, France, Germany, India

Drugs / interventions tested

• lanreotide (Autogel formulation) — full drug profile →
• Placebo

Conditions studied

• Endocrine Tumors — all drugs for Endocrine Tumors →

Sponsor

Ipsen — full company profile →

Who can join

18 and older, any sex, with Endocrine Tumors. 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.

• Progression-Free Survival (PFS)
  Time frame: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year
  Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0

Sponsor's own description

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

Publications & conference data

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

1. Lanreotide in metastatic enteropancreatic neuroendocrine tumors.
   Caplin ME, Pavel M, Ćwikła JB, Phan AT, et al · · 2014 · cited 1188× · PMID 25014687 · DOI 10.1056/nejmoa1316158
2. The expanding role of somatostatin analogs in the management of neuroendocrine tumors.
   Wolin EM. · · 2012 · cited 66× · PMID 23112884
3. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.
   Hilal T, Gonzalez-Velez M, Prasad V. · · 2020 · cited 65× · PMID 32539071 · DOI 10.1001/jamainternmed.2020.2250
4. Antitumor effects of somatostatin analogs in neuroendocrine tumors.
   Sidéris L, Dubé P, Rinke A. · · 2012 · cited 63× · PMID 22628056 · DOI 10.1634/theoncologist.2011-0458
5. 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
6. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.
   Martín-Richard M, Massutí B, Pineda E, Alonso V, et al · · 2013 · cited 54× · PMID 24053191 · DOI 10.1186/1471-2407-13-427
7. Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors.
   Dromain C, Pavel ME, Ruszniewski P, Langley A, et al · · 2019 · cited 53× · PMID 30642293 · DOI 10.1186/s12885-018-5257-x
8. Targeted therapies in neuroendocrine tumors (NET): clinical trial challenges and lessons learned.
   Yao JC, Lagunes DR, Kulke MH. · · 2013 · cited 36× · PMID 23615698 · DOI 10.1634/theoncologist.2012-0434