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
-

Treatment of Unresecable and/or Metastatic Merkel Cell Carcinoma by Somatostatine Analogues

Phase 2
Completed
Conditions
Carcinoma, Merkel Cell
Interventions
First Posted Date
2015-01-30
Last Posted Date
2017-10-18
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
35
Registration Number
NCT02351128
Locations
🇫🇷

Grenoble University Hospital, Grenoble, France

A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

Phase 2
Terminated
Conditions
Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Interventions
Drug: Placebo
Drug: lanreotide
First Posted Date
2014-11-11
Last Posted Date
2023-01-18
Lead Sponsor
Federation Francophone de Cancerologie Digestive
Target Recruit Count
53
Registration Number
NCT02288377
Locations
🇩🇪

University Hospital Marburg, Marburg, Germany

🇫🇷

Hôpital de la Milétrie, Poitiers, France

🇫🇷

CHU Charles Nicolle, Rouen, France

and more 21 locations

Lanreotide In Polycystic Kidney Disease Study

Phase 3
Completed
Conditions
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Interventions
Drug: Lanreotide
Drug: saline
First Posted Date
2014-04-30
Last Posted Date
2019-11-18
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
159
Registration Number
NCT02127437
Locations
🇫🇷

Necker hospital, Paris, France

Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Phase 2
Conditions
Acid Reflux Esophagitis
Non-acid Reflux Esophagitis
Interventions
First Posted Date
2014-02-04
Last Posted Date
2014-02-04
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
10
Registration Number
NCT02054637
Locations
🇧🇪

University Hospital of Brussels, Jette, Belgium

A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

Phase 4
Terminated
Conditions
Acromegaly
Interventions
First Posted Date
2013-05-24
Last Posted Date
2021-09-30
Lead Sponsor
Saint John's Cancer Institute
Target Recruit Count
4
Registration Number
NCT01861717
Locations
🇺🇸

Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System, Santa Monica, California, United States

A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

Phase 2
Conditions
Carcinoid Tumors
Interventions
Drug: Lanreotide
Drug: Placebo (for sunitinib)
Drug: Sunitinib
First Posted Date
2012-11-22
Last Posted Date
2017-01-31
Lead Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Target Recruit Count
44
Registration Number
NCT01731925
Locations
🇧🇪

UZ Leuven, Leuven, Belgium

🇫🇷

Hôpital Henri Mondor, Créteil, France

🇧🇪

ULB Erasme, Brussels, Belgium

and more 17 locations

Study of Lanreotide to Treat Polycystic Kidney Disease

Phase 3
Conditions
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Interventions
First Posted Date
2012-06-12
Last Posted Date
2017-05-23
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
300
Registration Number
NCT01616927
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

🇳🇱

Radboud University Medical Center, Nijmegen, Netherlands

🇳🇱

Leiden University Medical Center, Leiden, Netherlands

and more 1 locations

Acromegaly Combination Treatment Study

Not Applicable
Terminated
Conditions
Acromegaly
Interventions
First Posted Date
2012-02-27
Last Posted Date
2023-01-04
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
76
Registration Number
NCT01538966
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

Completed
Conditions
Polycystic Liver Disease
Interventions
First Posted Date
2011-05-16
Last Posted Date
2014-07-09
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
43
Registration Number
NCT01354405
Locations
🇳🇱

Radboud University Hospital, Nijmegen, Gelderland, Netherlands

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

Phase 3
Completed
Conditions
Carcinoid Syndrome
Interventions
Drug: Placebo
Drug: Lanreotide
First Posted Date
2008-10-17
Last Posted Date
2022-10-14
Lead Sponsor
Ipsen
Target Recruit Count
115
Registration Number
NCT00774930
Locations
🇺🇸

VA Greater Los Angeles Health Care System, Los Angeles, California, United States

🇿🇦

Westridge Medical Centre, Durban, South Africa

🇺🇦

Medical Centre "Mriya", Kyiv, Ukraine

and more 51 locations
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