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

July 18, 2023 updated by: Changhoon Yoo, Asan Medical Center

Prospective Observational Study to Assess the Effectiveness and Safety of Lanreotide Autogel® in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Asia Region

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Changhoon Yoo
        • Contact:
        • Principal Investigator:
          • Changhoon Yoo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

G1-2 GEP-NET patients who would be treated with lanreotide will be included in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lanreotide
Patients treated with lanreotide
Drug: Lanreotide autogel
Lanreotide autogel 90-120 mcg, every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate at 2 years
Time Frame: 2 years
Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2 years
Time between lanreotide treatment initiation and disease progression or death
2 years
Response rates
Time Frame: 2 years
Proportion of patients with tumor response by RECIST version 1.1
2 years
Disease control rates
Time Frame: 2 years
Proportion of patients with tumor response and stable disease by RECIST version 1.1
2 years
Overall survival
Time Frame: 2 years
Time between lanreotide treatment initiation and death due to any cause
2 years
Chromogranin A response
Time Frame: 2 years
Change of serum chromogranin A levels during lanreotide treatment
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Samsung Medical Center
Seoul St. Mary's Hospital
Seoul National University Bundang Hospital
Severance Hospital

Investigators

  • Principal Investigator: Changhoon Yoo, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIM-NETs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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