Spots Global Cancer Trial Database for Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
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Trial Identification
Brief Title: Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
Official Title: A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study
Study ID: NCT01374451
Conditions
Study Description
Brief Summary: This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET. A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute SC-2, Boston, Massachusetts, United States
Montefiore Medical Center MMC, Bronx, New York, United States
Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, United States
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr, Houston, Texas, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, St. Leonards, New South Wales, Australia
Novartis Investigative Site, Herston, Queensland, Australia
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Haine-saint-Paul, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Copenhagen N, , Denmark
Novartis Investigative Site, Århus, , Denmark
Novartis Investigative Site, Bordeaux Cedex, , France
Novartis Investigative Site, Clichy, , France
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Marseille cedex 05, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, München, , Germany
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Modena, MO, Italy
Novartis Investigative Site, Fukuoka-city, Fukuoka, Japan
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Grafton, Auckland, , New Zealand
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Lund, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, Glasgow, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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