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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00434148
First received: February 9, 2007
Last updated: July 31, 2013
Last verified: July 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.


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: Month 1, 2, 3, 4, 5, 6, 12 and every 3 months to study end. ] [ Designated as safety issue: No ]
  • Assessment of Plasma ACTH and Serum Cortisol Level [ Time Frame: Month 1, 2, 3, 4, 5, 6, 12 and every 3 months to study end. ] [ Designated as safety issue: No ]
  • Assessment of Clinical Signs and Symptoms [ Time Frame: Month 1, 2, 3, 4, 5, 6, 12 and every 3 months to study end. ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600ug b.i.d
All patients received a double blind dose of 600 µg subcutaneously ( s.c.) two times a day ( b.i.d) Pasireotide. Patients continued at this dose until Month 6 (double-blind treatment if their Month 3 mUFC was a ≤2 X ULN and b) below or equal to their baseline mUFC. Patients not meeting these mUFC criteria at Month 3 were unblinded and were required to increase their dose to 900 µg b.i.d, given on an open-label basis. These patients were classified as non-responders for the Month 6 Primary analysis. Patients who did not escalate to the 900 µg b.i.d dose were to be discontinued from the study.
Drug: Pasireotide
All patients received Pasireotide subcutaneously (s.c.) twice a day (b.i.d) at either 600 µg or 900 µg doses. Patients self administered the drug (subcutaneous injections) after they received instruction from the site staff or investigator on the correct procedures.
Experimental: 900ug b.i.d
All patients received a double blind dose of 900 µg subcutaneously ( s.c.) two times a day ( b.i.d) Pasireotide. Patients continued at this dose until Month 6 (double-blind treatment) if their Month 3 mUFC was a) ≤ 2 x ULN and b)below or equal to their baseline mUFC. Patients not meeting these mUFC criteria at Month 3 were unblended and were offered to increase their dose to 1200 µg b.i.d., given on an open-label basis. These patients were classified as non-responders for the Month 6 Primary analysis. Patients who did not escalate to the 1200 µg b.i.d dose were to be discontinued from the study. [China only: Patients in the 900 µg b.i.d dose group were not offered to have their dose increased to 1200 µg b.i.d but had to be discontinued.
Drug: Pasireotide
All patients received Pasireotide subcutaneously (s.c.) twice a day (b.i.d) at either 600 µg or 900 µg doses. Patients self administered the drug (subcutaneous injections) after they received instruction from the site staff or investigator on the correct procedures.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States, 94304
United States, Illinois
University Chicago Hospital Dept. of Univ of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute The Melanoma Program
Boston, Massachusetts, United States, 02115
United States, New York
Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.
Dallas, Texas, United States, 75390-8527
MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(8)
Houston, Texas, United States, 77030-4009
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, United States
Argentina
Novartis Investigative Site
Capital Federal, Buenos Aires, Argentina, 1425EKP
Novartis Investigative Site
Buenos Aires, Argentina, C1405BCH
Novartis Investigative Site
Buenos Aires, Argentina, C1232AAC
Belgium
Novartis Investigative Site
Edegem, Belgium, 2650
Novartis Investigative Site
Gent, Belgium, 9000
Brazil
Novartis Investigative Site
Curitiba, PR, Brazil, 80060-900
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90035-903
Novartis Investigative Site
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site
São Paulo, SP, Brazil, 01401-901
Novartis Investigative Site
São Paulo, SP, Brazil, 05403-000
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2S2
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2W 1T8
China
Novartis Investigative Site
Beijing, China, 100853
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Shanghai, China, 200025
Denmark
Novartis Investigative Site
Arhus, Denmark, 8000
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Novartis Investigative Site
Herlev, Denmark, DK-2730
Finland
Novartis Investigative Site
Helsinki, Finland, FIN-00290
France
Novartis Investigative Site
Angers, France, 49033
Novartis Investigative Site
Grenoble Cédex 9, France, 38043
Novartis Investigative Site
LILLE Cedex, France, 59037
Novartis Investigative Site
Limoges cedex, France, 87042
Novartis Investigative Site
Marseille cedex 05, France, 13385
Novartis Investigative Site
Paris, France, 75006
Novartis Investigative Site
Pessac Cedex, France, 33604
Novartis Investigative Site
St Priest en Jarez Cedex, France, 42277
Novartis Investigative Site
Toulouse Cedex 9, France, 31059
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
Würzburg, Germany, 97080
Greece
Novartis Investigative Site
Athens, Greece, GR 10552
Novartis Investigative Site
Athens, Greece, GR 156 69
Israel
Novartis Investigative Site
Heifa, Israel, 35152
Novartis Investigative Site
Jerusalem, Israel, 91120
Novartis Investigative Site
Petach Tikva, Israel, 49100
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Milano, MI, Italy, 20149
Novartis Investigative Site
Milano, MI, Italy, 20162
Novartis Investigative Site
Padova, PD, Italy, 35128
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Napoli, Italy, 80131
Novartis Investigative Site
Pisa, Italy, 56124
Mexico
Novartis Investigative Site
México, Distrito Federal, Mexico, 06720
Novartis Investigative Site
México, Distrito Federal, Mexico, 14269
Poland
Novartis Investigative Site
Warszawa, Poland, 01 809
Portugal
Novartis Investigative Site
Porto, Portugal, 4200-319
Spain
Novartis Investigative Site
Sevilla, Andalucía, Spain, 41013
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08025
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Istanbul, Turkey, 34303
Novartis Investigative Site
Izmir, Turkey, 35340
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00434148     History of Changes
Other Study ID Numbers: CSOM230B2305, 2006-004111-22
Study First Received: February 9, 2007
Results First Received: January 3, 2013
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Keywords provided by Novartis:
Cushing's Disease
pasireotide
SOM230

Additional relevant MeSH terms:
Cushing Syndrome
Pituitary ACTH Hypersecretion
Adrenal Gland Diseases
Adrenocortical Hyperfunction
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 20, 2014