EUCTR2013-002170-49-NL
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cushing's disease
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients with confirmed diagnosis of ACTH\-dependent Cushing’s disease
- •2\. Patients with de novo Cushing’s disease can be included only if they are not considered candidates for pituitary surgery
- •3\. Male or female patients aged 18 years or greater
- •4\. Karnofsky performance status \= 60 (i.e. requires occasional assistance, but is able to care for most of their personal
- •5\.Patients on medical treatment for Cushing’s disease the following washout periods must be completed before
- •screening assessments are performed
- •6\.Patients have been on pasireotide in the past but discontinued
- •because of lack of efficacy are also allowed to enter Group 1\. Patients treated with pasireotide subcutaneously must have been discontinued from the treatment for at least 4 weeks before
- •screening. Patients treated with pasireotide LAR must have been
- •discontinued from the treatment for at least 12 weeks before screening.
Exclusion Criteria
- •Exclusion criteria for Group 1 and Group 2:
- •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 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
- •8\. Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST \> 2 X ULN, serum bilirubin \>2\.0 X ULN
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseCushing's diseaseEUCTR2013-002170-49-GRovartis Pharma Services AG128
Active, not recruiting
Phase 1
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 diseaseEUCTR2013-002170-49-HUovartis Pharma Services AG64
Active, not recruiting
Phase 1
A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseCushing's diseaseEUCTR2013-002170-49-FRovartis Pharma Services AG128
Active, not recruiting
Phase 1
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 diseaseEUCTR2013-002170-49-DEovartis Pharma Services AG64
Completed
Phase 2
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 diseaseCushing's disease10021112NL-OMON42150ovartis2