Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

Completed · Phase 3

Conditions studied: Symptomatic Refractory Resistant Carcinoid Disease

In brief

The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

Key facts

Study ID

NCT00690430

Run by

Novartis Pharmaceuticals

People needed

186

Starts

2008-04-01

Expected to finish

2012-04-01

Last updated by the study team

2013-07-30

Who can join

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

You may qualify if…

• Male or female patients aged 18 or greater
• Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
• Female patients of child bearing potential must have a negative pregnancy test at baseline.
• Patients for whom written informed consent to participate in the study has been obtained.

You may not qualify if…

• Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
• Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C > 8%
• Patients with symptomatic cholelithiasis
• Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Arizona / Arizona Cancer Center — Tucson, Arizona, United States
• Loma Linda University Dept. of Loma Linda CancerCent — Loma Linda, California, United States
• Cedars Sinai Medical Center Cedars Sinai 4 — Los Angeles, California, United States
• H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit — Tampa, Florida, United States
• Mount Sinai School of Medicine Study Coordinator — New York, New York, United States
• Montefiore Medical Center MMC — The Bronx, New York, United States
• Duke University Medical Center Dept. of Duke Cancer Center(2) — Durham, North Carolina, United States
• St. Luke's Hospital and Health Network St. Luke's Cancer Network — Bethlehem, Pennsylvania, United States
• MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9) — Houston, Texas, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Halifax, Nova Scotia, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Nice, France, France
• Novartis Investigative Site — Strasbourg, France, France
• Novartis Investigative Site — Clichy, France
• Novartis Investigative Site — Dijon, France
• Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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