Last updated on December 2016

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in a Novartis-sponsored Study.


Brief description of study

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

Detailed Study Description

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored, Oncology CD&MA study and who are benefiting from treatment with pasireotide. Eligible patients are to be consented and can then continue treatment with pasireotide in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected. A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment. The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

Clinical Study Identifier: NCT01794793

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Sunil Bhoyrul

Ximed Research SC - SOM230B2412
La Jolla, CA United States
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Andrew E Hendifar

Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, CA United States
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Laurence Katznelson

Stanford University Medical Center Stanford Hospital & Clinics
Stanford, CA United States
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Ariel Barkan

University of Michigan Comprehensive Cancer Center SC-2
Ann Arbor, MI United States
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Eliza B. Geer

Icahn School of Medicine at Mount Sinai Icahn Sch of Med at Mount Sina
New York, NY United States
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Eliza B. Geer

Memorial Sloan-Kettering Cancer Center SC
New York, NY United States
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James LaRocque

Virginia Endocrinology Research SC
Chesapeake, VA United States
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Kevin Yuen

Swedish Cancer Institute Swedish Cancer Institute (SC)
Seattle, WA United States
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Caba, Argentina
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Brugge, Belgium
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Brussel, Belgium
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Bruxelles, Belgium
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Edegem, Belgium
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Gent, Belgium
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Leuven, Belgium
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Liege, Belgium
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Wilrijk, Belgium
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Montreal, QC Canada
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Guangzhou, China
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Angers, France
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Bron Cedex, France
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Le Kremlin Bicetre, France
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Lille Cedex, France
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Marseille cedex 05, France
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Pessac Cedex, France
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Pierre-Benite Cedex, France
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Toulouse Cedex 9, France
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Berlin, Germany
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Hamburg, Germany
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Muenchen, Germany
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München, Germany
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Ulm, Germany
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Würzburg, Germany
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Vellore, India
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Petach Tikva, Israel
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Seoul, Korea, Republic of
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Balcova / Izmir, Turkey
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