Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00434148

Purpose

This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.

Condition	Intervention	Phase
Cushing's Disease	Drug: Pasireotide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) sc Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Resource links provided by NLM:

MedlinePlus related topics: Cushing's Syndrome

Drug Information available for: Pasireotide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Efficacy assessed by urinary free cortisol levels after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of UFC at months 3 and 12 [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Time to first response [ Time Frame: over entire study period ] [ Designated as safety issue: No ]
Assessment of plasma ACTH and serum cortisol level [ Time Frame: over entire study period ] [ Designated as safety issue: No ]
Assessment of clinical signs and symptoms [ Time Frame: over the entire study period ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: over the entire study period ] [ Designated as safety issue: Yes ]

Enrollment:	162
Study Start Date:	December 2006
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
600ug b.i.d: Experimental	Drug: Pasireotide
900ug b.i.d: Experimental	Drug: Pasireotide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

18 years or greater
Confirmed diagnosis of ACTH-dependent Cushing's disease
Not considered candidate for pituitary surgery

Exclusion criteria

History of pituitary irradiation in the last 10 years
Cushing's syndrome not caused by pituitary tumor
Patients with active malignant disease (cancer) in the last 5 years
Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434148

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford Cancer Center
Stanford, California, United States, 94305
UCLA Med-Endo
Los Angeles, California, United States, 90095
United States, Colorado
Denver Research Institute - VA Medical Center
Denver, Colorado, United States, 80220
United States, Florida
University of Florida - Division of Endocrinology
Gainesville, Florida, United States, 32610
United States, Illinois
University Chicago Hospital
Chicago, Illinois, United States, 60637
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic, Endocrine & Metabolic Institute
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8857
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Seattle Neuroscience Specialists
Seattle, Washington, United States, 98122
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98493
United States, Wisconsin
Midwest Endocrinology Associates, St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSOM230B2305
Study First Received:	February 9, 2007
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00434148 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Brazil: National Health Surveillance Agency; Canada: Health Canada; China: Ministry of Health; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: German Institute of Medical Documentation and Information; Greece: National Organization of Medicines; Italy: The Italian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Spain: Ministry of Health and Consumption; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Novartis:

Cushing's Disease
pasireotide
SOM230

Additional relevant MeSH terms:

Hypothalamic Diseases
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Nervous System Diseases
Cushing Syndrome

Central Nervous System Diseases
Endocrine System Diseases
Adrenal Gland Diseases
Brain Diseases
Adrenocortical Hyperfunction

ClinicalTrials.gov processed this record on February 08, 2010