Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

• Status: Completed
• Trial end date: 2016-12-21
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pasireotide

Criteria

Inclusion Criteria:

• Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)

• For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

• Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week

• Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks

• Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks

• Octreotide (immediate release formulation): 1 week

Exclusion Criteria:

• Patients who are considered candidates for surgical treatment at the time of study entry

• Patients who have received pituitary irradiation within the last ten years prior to visit 1

• Patients who have had any previous pasireotide treatment

• Patients who have been treated with mitotane during the last 6 months prior to Visit 1

• Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c >8%

• Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval

• Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid