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

Completed · Phase 3

Conditions studied: Cushing's Disease

In brief

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.

Key facts

Study ID

NCT01374906

Run by

Novartis Pharmaceuticals

People needed

150

Starts

2011-11-04

Expected to finish

2016-12-21

Last updated by the study team

2018-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at Los Angeles UCLA Tiverton — Los Angeles, California, United States
• Harbor-UCLA Medical Center LA Biomed — Torrance, California, United States
• Emory University School of Medicine/Winship Cancer Institute G2304 - C2301 — Atlanta, Georgia, United States
• Pituitary Center, Division of Endocrinology SC — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center SC-2 — Ann Arbor, Michigan, United States
• Mount Sinai School of Medicine Mt. Sinai Medical Center — New York, New York, United States
• Oregon Health & Sciences University DeptofOregonHealth&Sciences(2) — Portland, Oregon, United States
• University of Pennsylvania - Clinical Studies Unit Unniv SC — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center CSOM230G2304 — Nashville, Tennessee, United States
• Swedish Medical Center Swedish — Seattle, Washington, United States
• Medical College of Wisconsin MCW 2 — Milwaukee, Wisconsin, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Edegem, Antwerpen, Belgium
• Novartis Investigative Site — Jette, Brussels Capital, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Ribeirão Preto, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Halifax, Nova Scotia, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• ClinTriCo — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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