MedPath

Sotrastaurin

Generic Name
Sotrastaurin
Drug Type
Small Molecule
Chemical Formula
C25H22N6O2
CAS Number
425637-18-9
Unique Ingredient Identifier
7I279E1NZ8
Background

Sotrastaurin has been used in trials studying the basic science and treatment of Uveal Melanoma, Richter Syndrome, Prolymphocytic Leukemia, Recurrent Mantle Cell Lymphoma, and Recurrent Small Lymphocytic Lymphoma, among others.

Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

Phase 2
Completed
Conditions
Posterior Uveitis
Uveitis
Panuveitis
Interventions
First Posted Date
2008-02-14
Last Posted Date
2020-12-22
Lead Sponsor
Novartis
Target Recruit Count
13
Registration Number
NCT00615693
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Southern California Doheny Eye Institute, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

John Hopkins Hospital/Wilmer Eye Institute, Baltimore, Maryland, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of California, San Francisco, California, United States

and more 10 locations

Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: Placebo
First Posted Date
2007-12-13
Last Posted Date
2020-12-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
60
Registration Number
NCT00572585
Locations
๐Ÿ‡ต๐Ÿ‡ฑ

Novartis Investigative Site, Poznan, Poland

24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

Phase 2
Terminated
Conditions
Kidney Transplantation
Interventions
Drug: mycophenolic plus tacrolimus
First Posted Date
2007-11-09
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
137
Registration Number
NCT00555789
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Novartis Investigative Site, Manchester, United Kingdom

Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

Phase 1
Completed
Conditions
de Novo Liver Transplantation
Interventions
First Posted Date
2007-10-17
Last Posted Date
2020-12-08
Lead Sponsor
Novartis
Target Recruit Count
13
Registration Number
NCT00545259
Locations
๐Ÿ‡จ๐Ÿ‡ญ

Novartis investigative site, Zurich, Switzerland

๐Ÿ‡ฎ๐Ÿ‡น

Novartis Investigative Site, Padova, Italy

Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

Phase 2
Completed
Conditions
Kidney Transplantation
Interventions
First Posted Date
2007-07-20
Last Posted Date
2016-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
311
Registration Number
NCT00504543
Locations
๐Ÿ‡ฆ๐Ÿ‡ท

Argentina, Buenos Aires, Argentina

๐Ÿ‡ง๐Ÿ‡ช

Belgium, Gent, Belgium

๐Ÿ‡จ๐Ÿ‡ณ

Novartis Investigative Site, Taipie, Taiwan

and more 9 locations

Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

Phase 1
Completed
Conditions
Kidney Transplantation
First Posted Date
2007-06-27
Last Posted Date
2020-12-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
124
Registration Number
NCT00492869
Locations
๐Ÿ‡บ๐Ÿ‡ธ

USC Medical Center, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Cincinnati, Dept of Internal Medicine, Cincinnati, Ohio, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Colorado Health Science Center, Denver, Colorado, United States

and more 38 locations

Safety of AEB071 in Healthy Volunteers and to Compare the Ethnicity, Metabolic, and Safety Effects Between Caucasian and Japanese Healthy Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-12-28
Last Posted Date
2008-08-11
Lead Sponsor
Novartis
Target Recruit Count
96
Registration Number
NCT00416546
Locations
๐Ÿ‡จ๐Ÿ‡ฆ

Novartis Investigative Site, Dorval, Quebec, Canada

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-12-12
Last Posted Date
2010-10-19
Lead Sponsor
Novartis
Target Recruit Count
16
Registration Number
NCT00409929
Locations
๐Ÿ‡จ๐Ÿ‡ญ

Novartis Investigative Site, Bern, Switzerland

Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

Phase 1
Completed
Conditions
Kidney Transplantation
Interventions
First Posted Date
2006-11-23
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
215
Registration Number
NCT00403416
Locations
๐Ÿ‡จ๐Ÿ‡ญ

Inselspital Bern, Bern, Switzerland

๐Ÿ‡ฎ๐Ÿ‡น

Azienda Ospedaliera di Padova - Universita degli Studi, Padova, Italy

๐Ÿ‡บ๐Ÿ‡ธ

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

and more 25 locations
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