Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
NCT ID: NCT01628913
Last Updated: 2016-04-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2012-10-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BEZ235
Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
BEZ235
BEZ235 400 mg bid p.o. (by mouth, twice daily)
Everolimus
Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
Everolimus
Everolimus 10 mg qd p.o. (by mouth, daily)
Interventions
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BEZ235
BEZ235 400 mg bid p.o. (by mouth, twice daily)
Everolimus
Everolimus 10 mg qd p.o. (by mouth, daily)
Eligibility Criteria
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Inclusion Criteria
* Progressive disease within the last 12 months
* Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT
Exclusion Criteria
* Patients with more than 2 prior systemic treatment regimens
* Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
The Bronx, New York, United States
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Reims, , France
Novartis Investigative Site
Toulouse, , 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', , Russia
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Lucerne, , 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
Countries
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References
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Salazar R, Garcia-Carbonero R, Libutti SK, Hendifar AE, Custodio A, Guimbaud R, Lombard-Bohas C, Ricci S, Klumpen HJ, Capdevila J, Reed N, Walenkamp A, Grande E, Safina S, Meyer T, Kong O, Salomon H, Tavorath R, Yao JC. Phase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor-Naive Advanced Pancreatic Neuroendocrine Tumors. Oncologist. 2018 Jul;23(7):766-e90. doi: 10.1634/theoncologist.2017-0144. Epub 2017 Dec 14.
Other Identifiers
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CBEZ235Z2401
Identifier Type: OTHER
Identifier Source: secondary_id
2012-000769-19
Identifier Type: -
Identifier Source: secondary_id
CBEZ235Z2401
Identifier Type: -
Identifier Source: org_study_id
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