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

  Show 67 Study Locations
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
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014