Pasireotide

Generic Name: Pasireotide

Brand Names: Signifor

Drug Type: Small Molecule

Chemical Formula: C_₅₈H_₆₆N_₁₀O_₉

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

Clinical Trials

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

Phase 2

Completed

Conditions: Acromegaly
Pituitary Gigantism

Interventions: Drug: Pasireotide LAR

First Posted Date: 2012-08-28

Last Posted Date: 2019-09-16

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 33

Registration Number: NCT01673646

Locations: 🇯🇵
Novartis Investigative Site, Yamagata, Japan

Pasireotide LAR in Severe Polycystic Liver Disease

Phase 2

Completed

Conditions: Somatostatin Analogs
Polycystic Liver Disease
Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Liver Disease

Interventions: Drug: Pasireotide LAR
Drug: Placebo

First Posted Date: 2012-08-21

Last Posted Date: 2020-05-01

Lead Sponsor: Mayo Clinic

Target Recruit Count: 48

Registration Number: NCT01670110

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel Cell Carcinoma

Phase 1

Completed

Conditions: Metastatic Melanoma and Merkel Cell Carcinoma

Interventions: Drug: Pasireotide sub-cutaneous formulation
Drug: Pasireotide lon acting release formulation

First Posted Date: 2012-07-30

Last Posted Date: 2020-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 10

Registration Number: NCT01652547

Locations: 🇨🇭
Novartis Investigative Site, Zuerich, Switzerland

Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Pasireotide LAR in Patients With Castration Resistant Prostate Cancer

Phase 1

Completed

Conditions: Castration Resistant Prostate Cancer

Interventions: Drug: SOM230

First Posted Date: 2012-07-20

Last Posted Date: 2020-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 9

Registration Number: NCT01646684

Locations: 🇩🇪
Novartis Investigative Site, Tübingen, Germany

Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

Phase 2

Completed

Conditions: Dumping Syndrome

Interventions: Drug: SOM230

First Posted Date: 2012-07-11

Last Posted Date: 2017-05-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 43

Registration Number: NCT01637272

Locations: 🇺🇸
Virginia Endocrinology Research SC, Chesapeake, Virginia, United States
🇺🇸
Montefiore Medical Center CLCZ696B2320, Bronx, New York, United States
🇳🇱
Novartis Investigative Site, Utrecht, Netherlands

and more 4 locations

Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

Phase 2

Completed

Conditions: Non-functioning Pituitary Adenomas
Prolactinomas

Interventions: Drug: Pasireotide
Drug: cabergoline

First Posted Date: 2012-06-15

Last Posted Date: 2016-08-22

Lead Sponsor: Universidade Federal do Rio de Janeiro

Target Recruit Count: 21

Registration Number: NCT01620138

Locations: 🇧🇷
Endocrinology Section - Hospital Universitário Clementino Fraga Filho/Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil

Pasireotide Therapy in Patients With Nelson's Syndrome

Phase 2

Terminated

Conditions: Nelson Syndrome

Interventions: Drug: Pasireotide

First Posted Date: 2012-06-12

Last Posted Date: 2016-11-02

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Target Recruit Count: 8

Registration Number: NCT01617733

Locations: 🇬🇧
Barts and the London NHS Trust, London, United Kingdom
🇬🇧
The Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
🇬🇧
Oxford University Hospitals NHS Trust, Oxford, United Kingdom

and more 1 locations

Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

Phase 1

Completed

Conditions: Neuroendocrine Tumors

Interventions: Drug: RAD001
Drug: SOM230

First Posted Date: 2012-05-02

Last Posted Date: 2019-04-16

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 18

Registration Number: NCT01590199

Locations: 🇩🇪
Novartis Investigative Site, Muenster, Germany

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.

Phase 3

Completed

Conditions: Cushing's Disease

Interventions: Drug: Pasireotide sub-cutaneous

First Posted Date: 2012-04-20

Last Posted Date: 2018-06-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 104

Registration Number: NCT01582061

Locations: 🇺🇸
Advanced Research, LLC, Peoria, Arizona, United States
🇺🇸
Mount Sinai School of Medicine, New York, New York, United States
🇺🇸
Diabetes and Endocrinology Associates, PC, Omaha, Nebraska, United States

and more 15 locations

A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: SOM230

First Posted Date: 2012-04-17

Last Posted Date: 2020-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 50

Registration Number: NCT01578928

Locations: 🇿🇦
Novartis Investigative Site, Bloemfontein, Free State, South Africa

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