Status:
COMPLETED
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cushing's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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 apply.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00434148
Start Date
December 1 2006
End Date
May 1 2014
Last Update
March 8 2016
Active Locations (68)
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1
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States, 94304
2
University Chicago Hospital Dept. of Univ of Chicago
Chicago, Illinois, United States, 60637
3
Dana Farber Cancer Institute The Melanoma Program
Boston, Massachusetts, United States, 02115
4
Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
New York, New York, United States, 10032