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Trial · Observational

CompletedPhase not statedRegistry data

Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs

Short name AIM-NETs

NCTNCT04696042 (opens ClinicalTrials.gov in a new tab)Other idAIM-NETs
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
71 participants (actual)
Sponsor
Asan Medical Center · Other
Design
Not stated
Countries
1 country

South Korea

Start
1 Jan 2021
Primary completion
30 Jan 2024
Completion
27 Jan 2025
First posted
6 Jan 2021
Last update posted
28 Jan 2025
Conditions
Neuroendocrine Tumors

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023202420252026
  1. Ph –

    AIM-NETs

    NCT04696042

    1 Jan 2021 to 27 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial. According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.

Interventions

  • Lanreotide autogelDrug

Arms1

  • Other

    Lanreotide

    Patients treated with lanreotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression-free survival rate at 2 years

    Time frame · 2 years

    Registry description

    Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years

Secondary outcomes(5)

  1. Progression-free survival

    Time frame · 2 years

    Registry description

    Time between lanreotide treatment initiation and disease progression or death

  2. Response rates

    Time frame · 2 years

    Registry description

    Proportion of patients with tumor response by RECIST version 1.1

  3. Disease control rates

    Time frame · 2 years

    Registry description

    Proportion of patients with tumor response and stable disease by RECIST version 1.1

  4. Overall survival

    Time frame · 2 years

    Registry description

    Time between lanreotide treatment initiation and death due to any cause

  5. Chromogranin A response

    Time frame · 2 years

    Registry description

    Change of serum chromogranin A levels during lanreotide treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

6 results

Lanreotide in metastatic enteropancreatic neuroendocrine tumors.

Caplin et al. 2014The New England journal of medicinecited by 1,288

PMID 25014687DOI 10.1056/nejmoa1316158PUB-25014687

Rights unknown6 results
Source linkSee results (6)

More studies

1 study on this page

PubMed tag: none · 2019

Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis.

Kang et al. 2019Investigational new drugscited by 11

PMID 30536151DOI 10.1007/s10637-018-0710-xPUB-30536151

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 19 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Written informed consent * Male or female subject aged ≥18 years and legally capable to provide informed consent * Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET * Well differentiated tumor * Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria * Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study * Use of Lanreotide autogel® monotherapy by local label (SmPC). * Concomitant locoregional therapy such as surgery, RFA or TAE is allowed. Exclusion Criteria: * Parallel participation in an interventional study * Lanreotide treatment for more than 5 months prior inclusion into the study * Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR). * Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.

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