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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04696042
Collaborator
Samsung Medical Center (Other), Seoul St. Mary's Hospital (Other), Severance Hospital (Other), Seoul National University Bundang Hospital (Other)
95
Enrollment
1
Location
49
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanreotide autogel

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
95 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Lanreotide

Patients treated with lanreotide

Drug: Lanreotide autogel
Lanreotide autogel 90-120 mcg, every 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival rate at 2 years [2 years]

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

Secondary Outcome Measures

  1. Progression-free survival [2 years]

    Time between lanreotide treatment initiation and disease progression or death

  2. Response rates [2 years]

    Proportion of patients with tumor response by RECIST version 1.1

  3. Disease control rates [2 years]

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

  4. Overall survival [2 years]

    Time between lanreotide treatment initiation and death due to any cause

  5. Chromogranin A response [2 years]

    Change of serum chromogranin A levels during lanreotide treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhoon Yoo Seoul Korea, Republic of 138-736

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Changhoon Yoo, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Changhoon Yoo, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT04696042
Other Study ID Numbers:
  • AIM-NETs
First Posted:
Jan 6, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changhoon Yoo, Assistant Professor, Asan Medical Center
Neuroendocrine tumor
Somatostatin analogue
Additional relevant MeSH terms:
Neuroendocrine Tumors
Lanreotide

Study Results

No Results Posted as of Jul 20, 2022