Spots Global Cancer Trial Database for Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
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Trial Identification
Brief Title: Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Official Title: Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
Study ID: NCT01628913
Conditions
Study Description
Brief Summary: This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).
Detailed Description: Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars Sinai Medical Center SC-3, Los Angeles, California, United States
University of Colorado Univ Colorado, Aurora, Colorado, United States
University of Kentucky Univ Kebtucky, Lexington, Kentucky, United States
Montefiore Medical Center SC, Bronx, New York, United States
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Montpellier Cedex 5, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Reims, , France
Novartis Investigative Site, Toulouse Cedex 4, , France
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Pisa, PI, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Luzern, , Switzerland
Novartis Investigative Site, Glasgow, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Sheffield, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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