Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Cushing's Disease
About this trial
This is an interventional treatment trial for Cushing's Disease focused on measuring Cushing's Disease, pasireotide, SOM230
Eligibility 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 apply.
Sites / Locations
- Stanford University Medical Center Stanford Cancer Center (3)
- University Chicago Hospital Dept. of Univ of Chicago
- Dana Farber Cancer Institute The Melanoma Program
- Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
- Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)
- Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
- University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.
- University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
- Baylor College of Medicine
- Swedish Medical Center Dept.ofSeattle Neuroscience(2)
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pasireotide 600 ug
Pasireotide 900 ug
At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.