Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

Stopped early · Phase 2

Conditions studied: Pancreatic Neuroendocrine Tumors (pNET)

In brief

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).

Key facts

Study ID

NCT01628913

Run by

Novartis Pharmaceuticals

People needed

62

Starts

2012-10-01

Expected to finish

2014-09-01

Last updated by the study team

2016-04-07

Who can join

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

You may qualify if…

• Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
• Progressive disease within the last 12 months
• Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT

You may not qualify if…

• Prior treatment with mTOR or PI3K inhibitors
• Patients with more than 2 prior systemic treatment regimens
• Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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