An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly



Status:Completed
Conditions:Skin Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 80
Updated:8/12/2016
Start Date:August 2004
End Date:December 2013

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Trial Summary
Trial Overview
Inclusion Criteria

Extension to a Multi-center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth
hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess
the long-term safety and efficacy of pasireotide in patients with acromegaly.


Inclusion Criteria:

- Patients who have completed all four treatment regimens in the core study
CSOM230B2201 and achieved biochemical control in GH and IGF-1 levels after at least
one month of pasireotide administration at any of the three doses

- Patients who did not experience any unacceptable adverse events or tolerability
issues during the core study CSOM230B2201

Exclusion Criteria:

- Patients who experienced or developed compression of the optic chiasm causing any
visual field defect during the core study CSOM230B2201

- Patients who required a surgical intervention for relief of any sign or symptom
associated with tumor compression during the core study CSOM230B2201 Patients who
experienced or developed congestive heart failure, unstable angina, sustained
ventricular tachycardia, ventricular fibrillation or acute myocardial infraction
during the core study CSOM230B2201

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
4
sites
NYU / VA Medical Center
227 East 30th Street
New York, New York 10010
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New York, NY
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University of Michigan Health System StudyCoordinatorCSOM230B2201E1
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Cedars Sinai Medical Center Dept. of Pituitary Ctr.
Los Angeles, California 90048
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Los Angeles, CA
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Novartis Investigative Site
Woolloongabba, Queensland 4102
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Woolloongabba,
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