DRUG
Lanreotide autogel
Lanreotide autogel 90-120 mcg, every 4 weeks
Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs
Status
Completed
Phase
Not applicable
Enrollment
71
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 6, 2021
Study start
Jan 1, 2021
Primary completion
Jan 30, 2024
Study completion
Jan 27, 2025
Results posted
Not reported
Registry updated
Jan 28, 2025
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Progression-free survival
Time frame · 2 years
Time between lanreotide treatment initiation and disease progression or death
Response rates
Time frame · 2 years
Proportion of patients with tumor response by RECIST version 1.1
Disease control rates
Time frame · 2 years
Proportion of patients with tumor response and stable disease by RECIST version 1.1
Overall survival
Time frame · 2 years
Time between lanreotide treatment initiation and death due to any cause
Chromogranin A response
Time frame · 2 years
Change of serum chromogranin A levels during lanreotide treatment
Eligibility
Who can take part.
- Minimum age
- 19 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Changhoon Yoo
Seoul, Seoul, South Korea
Publications
Results and literature.
PMID 23091441 ↗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.PMID 21659833 ↗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.PMID 26731013 ↗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.PMID 30536151 ↗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.PMID 25014687 ↗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.
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