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

Neuroendocrine Tumors Clinical Trial

— AIM-NETs  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696042
• Other study ID #: AIM-NETs
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 30, 2025

Study information

• Verified date: July 2023
• Source: Asan Medical Center
• Contact: Changhoon Yoo
• Phone: +821099006798
• Email: cyoo.amc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Changhoon Yoo	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Asan Medical Center	Samsung Medical Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158. — View Citation

Gastrointestinal Pathology Study Group of Korean Society of Pathologists; Cho MY, Kim JM, Sohn JH, Kim MJ, Kim KM, Kim WH, Kim H, Kook MC, Park DY, Lee JH, Chang H, Jung ES, Kim HK, Jin SY, Choi JH, Gu MJ, Kim S, Kang MS, Cho CH, Park MI, Kang YK, Kim YW, Yoon SO, Bae HI, Joo M, Moon WS, Kang DY, Chang SJ. Current Trends of the Incidence and Pathological Diagnosis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Korea 2000-2009: Multicenter Study. Cancer Res Treat. 2012 Sep;44(3):157-65. doi: 10.4143/crt.2012.44.3.157. Epub 2012 Sep 30. — View Citation

Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10. — View Citation

Kim SJ, Kim JW, Oh DY, Han SW, Lee SH, Kim DW, Im SA, Kim TY, Heo DS, Bang YJ. Clinical course of neuroendocrine tumors with different origins (the pancreas, gastrointestinal tract, and lung). Am J Clin Oncol. 2012 Dec;35(6):549-56. doi: 10.1097/COC.0b013e31821dee0f. — View Citation

Pavel M, O'Toole D, Costa F, Capdevila J, Gross D, Kianmanesh R, Krenning E, Knigge U, Salazar R, Pape UF, Oberg K; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for the Management of Distant Metastatic Disease of Intestinal, Pancreatic, Bronchial Neuroendocrine Neoplasms (NEN) and NEN of Unknown Primary Site. Neuroendocrinology. 2016;103(2):172-85. doi: 10.1159/000443167. Epub 2016 Jan 5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate at 2 years	Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years	2 years
Secondary	Progression-free survival	Time between lanreotide treatment initiation and disease progression or death	2 years
Secondary	Response rates	Proportion of patients with tumor response by RECIST version 1.1	2 years
Secondary	Disease control rates	Proportion of patients with tumor response and stable disease by RECIST version 1.1	2 years
Secondary	Overall survival	Time between lanreotide treatment initiation and death due to any cause	2 years
Secondary	Chromogranin A response	Change of serum chromogranin A levels during lanreotide treatment	2 years