MedPath

Octreotide

Generic Name
Octreotide
Brand Names
Bynfezia, Mycapssa, Sandostatin
Drug Type
Biotech
CAS Number
83150-76-9
Unique Ingredient Identifier
RWM8CCW8GP
Background

Acromegaly is a disorder caused by excess growth hormone (GH), increasing the growth of body tissues and causing metabolic dysfunction. In most cases, it results from an anterior pituitary growth hormone-releasing tumor. Typically, the feet, hands, and face grow abnormally large; organomegaly and insulin resistance may also occur. Acromegaly is a life-threatening disease requiring life-long management.

Octreotide is a long-acting drug with pharmacologic activities that mimic those of the natural hormone, somatostatin, which inhibits the secretion of growth hormone. Additionally, it is used for the treatment of acromegaly and symptoms arising from various tumors, including carcinoid tumors and vasoactive intestinal tumors (VIPomas). In the past, octreotide has been administered solely by injection. On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly. This drug was developed by Chiasma Inc.

Indication

Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors. The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and lanreotide.

Associated Conditions
Acromegaly, Diarrhea, Metastatic Carcinoid Tumors
Associated Therapies
Long-term maintenance therapy

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

Phase 2
Terminated
Conditions
Recurrent Prostate Cancer
Stage I Prostate Cancer
Diarrhea
Stage IIB Prostate Cancer
Hormone-resistant Prostate Cancer
Stage IIA Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions
First Posted Date
2011-11-10
Last Posted Date
2014-11-24
Lead Sponsor
University of Southern California
Target Recruit Count
9
Registration Number
NCT01469338
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Effects of Sandostatin LAR® in Acromegaly

Phase 4
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2011-08-26
Last Posted Date
2024-07-24
Lead Sponsor
Columbia University
Target Recruit Count
21
Registration Number
NCT01424241
Locations
🇺🇸

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

Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

Phase 3
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2011-08-09
Last Posted Date
2017-08-17
Lead Sponsor
Chiasma, Inc.
Target Recruit Count
155
Registration Number
NCT01412424
Locations
🇭🇺

Military Hospital, State Health Center 2nd Department of Internal Medicine, Budapest, Hungary

🇲🇽

Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery, Mexico City, Mexico

🇭🇺

University of Pecs, Pecs, Hungary

and more 33 locations

Surgical Debulking of Pituitary Adenomas

Phase 4
Completed
Conditions
Pituitary Adenoma
Interventions
Procedure: transsphenoidal surgery
First Posted Date
2011-06-13
Last Posted Date
2016-08-29
Lead Sponsor
NYU Langone Health
Target Recruit Count
41
Registration Number
NCT01371643
Locations
🇺🇸

New York University School of Medicine, New York, New York, United States

Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

Phase 3
Terminated
Conditions
Acromegaly
Interventions
First Posted Date
2011-02-14
Last Posted Date
2013-09-20
Lead Sponsor
Endo Pharmaceuticals
Target Recruit Count
12
Registration Number
NCT01295060

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Phase 4
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2011-01-17
Last Posted Date
2017-03-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
70
Registration Number
NCT01278342
Locations
🇮🇹

Novarts Investigative Site, Naples, Italy

🇨🇭

Novartis Investigative Site, Lausanne, Switzerland

Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

Phase 2
Completed
Conditions
Advanced Pancreatic Neuroendocrine Tumor
Locally Advanced Pancreatic Neuroendocrine Tumor
Pancreatic Gastrinoma
Pancreatic Neuroendocrine Tumor G1
Pancreatic Neuroendocrine Tumor G2
Pancreatic Vipoma
Interventions
First Posted Date
2010-10-28
Last Posted Date
2022-08-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
150
Registration Number
NCT01229943
Locations
🇺🇸

Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States

🇺🇸

Kaiser Permanente-Redwood City, Redwood City, California, United States

🇺🇸

Kalispell Medical Oncology, Kalispell, Montana, United States

and more 391 locations

Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

Phase 1
Completed
Conditions
Gastrin-Producing Neuroendocrine Tumor
Lung Carcinoid Tumor
Metastatic Digestive System Neuroendocrine Tumor G1
Pancreatic Glucagonoma
Pancreatic Insulinoma
Pancreatic Polypeptide Tumor
Paraganglioma
Recurrent Digestive System Neuroendocrine Tumor G1
Recurrent Merkel Cell Carcinoma
Recurrent Pancreatic Neuroendocrine Carcinoma
Interventions
Biological: Cixutumumab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
First Posted Date
2010-09-17
Last Posted Date
2016-07-15
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
27
Registration Number
NCT01204476
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Everolimus and LongActing Octreotide Trial in Polycystic Livers

Phase 2
Completed
Conditions
Polycystic Liver Disease
Interventions
First Posted Date
2010-07-07
Last Posted Date
2015-06-29
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
44
Registration Number
NCT01157858
Locations
🇳🇱

Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Phase 3
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2010-06-04
Last Posted Date
2018-04-05
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
198
Registration Number
NCT01137682
Locations
🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

Swedish Neuroscience Institute 550 17th Avenue, Suite 500, Seattle, Washington, United States

and more 2 locations
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