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Pasireotide

Generic Name
Pasireotide
Brand Names
Signifor
Drug Type
Small Molecule
Chemical Formula
C58H66N10O9
CAS Number
396091-73-9
Unique Ingredient Identifier
98H1T17066
Background

Pasireotide is a synthetic long-acting cyclic hexapeptide with somatostatin-like activity. It is marketed as a diaspartate salt called Signifor, which is used in the treatment of Cushing's disease.

Indication

For the treatment of Cushing’s disease, specifically for those patients whom pituitary surgery has not been curative or is not an option.

Associated Conditions
Acromegaly, Cushing's Disease

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

Phase 3
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2015-02-03
Last Posted Date
2019-12-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
123
Registration Number
NCT02354508
Locations
🇬🇧

Novartis Investigative Site, Plymouth, United Kingdom

Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Completed
Conditions
Cushings Disease
Interventions
First Posted Date
2014-12-08
Last Posted Date
2024-10-14
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
152
Registration Number
NCT02310269
Locations
🇨🇦

Centre de recherche du CHUM CRCHUM, Montreal, Quebec, Canada

🇨🇦

CHUS - Hopital Fleurimont, Sherbrooke, Quebec, Canada

🇨🇦

CHUL Centre de recherche du CHU, Quebec, Canada

and more 51 locations

Pasireotide in Prevention of GI Toxicity

Phase 2
Completed
Conditions
Hematological Malignancies
Interventions
First Posted Date
2014-08-13
Last Posted Date
2021-11-17
Lead Sponsor
Anthony Sung, MD
Target Recruit Count
37
Registration Number
NCT02215070
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

First Posted Date
2014-02-12
Last Posted Date
2019-05-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
249
Registration Number
NCT02060383
Locations
🇺🇸

LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219, Torrance, California, United States

🇺🇸

Diabetes and Endocrine Associates La Mesa Location, Multiple Locations, California, United States

🇺🇸

East Coast Institute for Research East Coast Inst. for Res(ECIR), Jacksonville, Florida, United States

and more 13 locations

Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts

Phase 3
Completed
Conditions
Symptomatic Dominant Liver Cyst
Interventions
Procedure: Aspiration sclerotherapy
Drug: Placebo
First Posted Date
2014-01-29
Last Posted Date
2016-05-04
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
34
Registration Number
NCT02048319
Locations
🇳🇱

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology, Nijmegen, Netherlands

Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size

Phase 2
Completed
Conditions
Primary Inoperable Thymoma
Local Recurrent Thymoma
Interventions
First Posted Date
2013-12-27
Last Posted Date
2018-02-05
Lead Sponsor
Prof. Dr. Berthold Schalke
Target Recruit Count
16
Registration Number
NCT02021942
Locations
🇩🇪

Klinik und Poliklinik für Neurologie der Universität Regensburg, Regensburg, Bavaria, Germany

An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly

Conditions
Acromegaly
First Posted Date
2013-11-27
Last Posted Date
2015-12-29
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT01995734
Locations
🇺🇸

The Johns Hopkins University School of Medicine Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Harbor-UCLA Medical Center Center for Men's Health, Torrance, California, United States

🇺🇸

Sinai Hospital of Baltimore Sinai Hospital, Baltimore, Baltimore, Maryland, United States

and more 34 locations

Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease

Phase 2
Terminated
Conditions
Cushings Disease
Interventions
First Posted Date
2013-08-02
Last Posted Date
2020-09-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
68
Registration Number
NCT01915303
Locations
🇺🇸

Oregon Health and Science University SOM230B2411, Portland, Oregon, United States

🇹🇷

Novartis Investigative Site, Pendik / Istanbul, Turkey

🇺🇸

University of Alabama at Birmingham The Kirklin Clinic, Birmingham, Alabama, United States

Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

Phase 2
Completed
Conditions
Postoperative Dumping Syndrome
Interventions
Drug: Placebo
First Posted Date
2013-07-10
Last Posted Date
2013-07-10
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
9
Registration Number
NCT01895296
Locations
🇧🇪

University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Phase 4
Completed
Conditions
Acromegaly
Pituitary Tumors
Ectopic ACTH Secreting (EAS) Tumors
Melanoma Negative for bRAF
Cushing's Disease
Neuroendocrine Tumors
Prostate Cancer
Melanoma Negative for nRAS
Dumping Syndrome
Interventions
First Posted Date
2013-02-20
Last Posted Date
2024-10-01
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
337
Registration Number
NCT01794793
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center SC-2, Ann Arbor, Michigan, United States

🇮🇹

Milano Investigative Site, Milano, MI, Italy

🇺🇸

Ximed Research SC - SOM230B2412, La Jolla, California, United States

and more 6 locations
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