A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease

ovartis Pharma Services AG0 sites64 target enrollmentSeptember 17, 2013

Overview

No summary available.

Registry

who.int

Start Date

September 17, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Written informed consent obtained prior to any screening procedures.
•2\.Adult patients with confirmed diagnosis of ACTH\-dependent Cushing's disease
•3\.Patients with de novo Cushing's disease can be included only if they are not considered candidates for pituitary surgery
•4\.Male or female patients aged 18 years or greater
•5\.Karnofsky performance status \= 60
•6\.Patients on medical treatment for Cushing's disease following washout periods
•7\. Patients who meet any one of the following criteria:
•They are naïve to pasireotide
•They have received pasireotide in the past and have been discontinued because of lack of efficacy (2 weeks of washout prior to screening for patients treated with pasireotide subcutaneously and 12 weeks of washout prior to screening for patients treated with pasireotide LAR)
•Patients who are on maximal tolerated dose but have not achieved biochemical control

•1\.Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention
•2\.Diabetic patients with poor glycemic control as evidenced by HbA1c \>8%
•3\.Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \>450 ms in males, and \> 460 ms in females. hypokalemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
•4\.Patients with clinically significant valvular disease
•5\.Patients with Cushing's syndrome due to ectopic ACTH secretion
•6\.Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
•7\.Patients who have a known inherited syndrome as the cause for hormone over\-secretion (i.e. Carney Complex, McCune\-Albright syndrome, MEN\-1\)
•8\.Patients who are hypothyroid and not on adequate replacement therapy
•9\.Patients with symptomatic cholelithiasis
•10\.Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function