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

February 9, 2007
July 31, 2013
December 2006
May 2010   (final data collection date for primary outcome measure)
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.
Efficacy assessed by urinary free cortisol levels after 6 months of treatment
Complete list of historical versions of study NCT00434148 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy assessed by serum cortisol levels
  • Patient Quality of Life assessed by questionnaire
  • Efficacy assessed by clinical signs and symptoms of Cushing’s Disease
  • Pharmacokinetics
  • Efficacy assessed by tumor size
Not Provided
Not Provided
 
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cushing's Disease
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: 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.
    Intervention: Drug: Pasireotide
  • 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.
    Intervention: Drug: Pasireotide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
May 2010
May 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Portugal,   Turkey,   Spain,   Argentina,   Belgium,   Brazil,   Canada,   China,   Denmark,   Finland,   Germany,   Greece,   Israel,   Italy,   Mexico,   Poland
 
NCT00434148
CSOM230B2305, 2006-004111-22
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP