MedPath

Lanreotide

Generic Name
Lanreotide
Brand Names
Somatuline
Drug Type
Small Molecule
Chemical Formula
C54H69N11O10S2
CAS Number
108736-35-2
Unique Ingredient Identifier
0G3DE8943Y
Background

Lanreotide is a drug employed in the management of acromegaly (a hormonal condition caused by excess growth hormone) in addition to symptoms caused by neuroendocrine tumors, especially carcinoid syndrome. This drug is a long-acting analog of the drug somatostatin, a growth hormone inhibitor. Lanreotide is manufactured by the company, Ipsen Pharmaceuticals as lanreotide acetate, and marketed as Somatuline. It is approved in several countries worldwide, including the United Kingdom, Australia, and Canada. Lanreotide was first approved for use in the United States by the FDA on August 30, 2007.

Indication

Lanreotide is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy. It is also indicated in the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Lanreotide is additionally indicated for the treatment of adults with carcinoid syndrome - when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Associated Conditions
Acromegaly, Carcinoid Syndrome, Unresectable, locally advanced enteropancreatic neuroendocrine tumors, Unresectable, locally advanced well- or moderately-differentiated Gastroenteropancreatic Neuroendocrine Tumors, Unresectable, metastatic enteropancreatic neuroendocrine tumors, Unresectable, metastatic well- or moderately-differentiated Gastroenteropancreatic Neuroendocrine Tumors
Associated Therapies
-

Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Phase 3
Recruiting
Conditions
GEP-NET
Pancreatic NET
Gastroenteropancreatic Neuroendocrine Tumor
Gastroenteropancreatic Neuroendocrine Tumor Disease
Neuroendocrine Tumors
Carcinoid Tumor
Carcinoid
Interventions
First Posted Date
2022-07-28
Last Posted Date
2024-11-13
Lead Sponsor
RayzeBio, Inc.
Target Recruit Count
288
Registration Number
NCT05477576
Locations
🇪🇸

Research Facility, Zaragoza, Spain

Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

Phase 1
Recruiting
Conditions
Neuroendocrine Tumors,Gastroenteropancreatic
Interventions
First Posted Date
2021-09-17
Last Posted Date
2024-07-05
Lead Sponsor
National Health Research Institutes, Taiwan
Target Recruit Count
49
Registration Number
NCT05048901
Locations
🇨🇳

China Medical University Hospital, Taichung, Taiwan

🇨🇳

National Cheng Kung University Hospita, Tainan, Taiwan

🇨🇳

Changhua Christian Hospital, Changhua, Taiwan

and more 7 locations

A Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in GEP and NET

Phase 2
Conditions
Neuroendocrine Tumors
Metastatic Well Differentiated Neuroendocrine Neoplasm
Interventions
First Posted Date
2020-06-11
Last Posted Date
2021-09-05
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Target Recruit Count
69
Registration Number
NCT04427787
Locations
🇮🇹

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome

Phase 3
Withdrawn
Conditions
Small Intestinal NET
Carcinoid Heart Disease
Interventions
First Posted Date
2019-08-22
Last Posted Date
2020-02-05
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Registration Number
NCT04065165

LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

Phase 2
Recruiting
Conditions
Paraganglioma
Pheochromocytoma
Interventions
First Posted Date
2019-05-10
Last Posted Date
2022-10-07
Lead Sponsor
Antonio Fojo
Target Recruit Count
40
Registration Number
NCT03946527
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET

Phase 4
Conditions
Neuroendocrine Tumors
Interventions
First Posted Date
2017-03-17
Last Posted Date
2019-05-20
Lead Sponsor
Samsung Medical Center
Target Recruit Count
28
Registration Number
NCT03083210
Locations
🇰🇷

Youngsuk Park, Seoul, Korea, Republic of

Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors

Phase 1
Completed
Conditions
Gastroenteropancreatic Neuroendocrine Tumors
Interventions
First Posted Date
2017-02-06
Last Posted Date
2023-06-29
Lead Sponsor
Duke University
Target Recruit Count
22
Registration Number
NCT03043664
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

Lexington Medical Center, Columbia, South Carolina, United States

Lanreotide in the Treatment of Small Bowel Motility Disorders

Phase 2
Completed
Conditions
Gastrointestinal Motility Disorder
Intestinal Disease
Interventions
First Posted Date
2017-01-06
Last Posted Date
2021-01-15
Lead Sponsor
Northwell Health
Target Recruit Count
12
Registration Number
NCT03012594
Locations
🇺🇸

Long Island Jewish Medical Center, New Hyde Park, New York, United States

🇺🇸

Lenox Hill Hospital, New York, New York, United States

Circulating Tumor Cells and Tumor DNA in HCC and NET

Completed
Conditions
Carcinoma, Hepatocellular
Neuroendocrine Tumors
Interventions
Procedure: Radiofrequency ablation (RFA) or surgery
Drug: Lanreotide
Drug: Sorafenib
Drug: Everolimus
First Posted Date
2016-11-25
Last Posted Date
2021-04-28
Lead Sponsor
University of Aarhus
Target Recruit Count
167
Registration Number
NCT02973204
Locations
🇩🇰

Department of Hepatology and Gastroenterology, Aarhus, Aarhus C, Denmark

Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres

Phase 2
Terminated
Conditions
Carcinoid Tumors
Gastrointestinal Neoplasms
Neuroendocrine Tumors
Interventions
Drug: Lanreotide
Device: Y-90 microspheres
First Posted Date
2016-08-08
Last Posted Date
2023-12-05
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
6
Registration Number
NCT02859064
Locations
🇺🇸

Tennessee Oncology PLLC, Nashville, Tennessee, United States

🇺🇸

Rocky Mountain Cancer Center, Denver, Colorado, United States

🇺🇸

Research Medical Center/HCA Midwest, Kansas City, Missouri, United States

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