Study Stopped
This trial was terminated based on an interim analysis as BEZ235 did not demonstrate a progression free survival advantage to everolimus treatment.
Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
2 other identifiers
interventional
62
8 countries
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
April 7, 2016
CompletedApril 7, 2016
March 1, 2016
1.9 years
June 25, 2012
August 19, 2015
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.
up to approx. 18 months
Secondary Outcomes (3)
Objective Response Rate
up to approx. 18 months
Overall Survival (OS)
up to approx. 30 months
Time to Treatment Failure (TTF)
up to approx. 18 months
Study Arms (2)
BEZ235
EXPERIMENTALPatients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
Everolimus
ACTIVE COMPARATORPatients received Everolimus 10 mg qd p.o. (by mouth, daily)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Cedars Sinai Medical Center SC-3
Los Angeles, California, 90048, United States
University of Colorado Univ Colorado
Aurora, Colorado, 80045, United States
University of Kentucky Univ Kebtucky
Lexington, Kentucky, 40536-0098, United States
Montefiore Medical Center SC
The Bronx, New York, 10467, United States
Novartis Investigative Site
Lyon, 69437, France
Novartis Investigative Site
Montpellier, 34298, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Reims, 51092, France
Novartis Investigative Site
Toulouse, 31054, France
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
Amsterdam, 1105 AZ, Netherlands
Novartis Investigative Site
Groningen, 9713 GZ, Netherlands
Novartis Investigative Site
Kazan', 420029, Russia
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Novartis Investigative Site
Madrid, Madrid, 28034, Spain
Novartis Investigative Site
Madrid, Madrid, 28046, Spain
Novartis Investigative Site
Lucerne, 6000, Switzerland
Novartis Investigative Site
Glasgow, G11 6NT, United Kingdom
Novartis Investigative Site
London, NW3 2QG, United Kingdom
Novartis Investigative Site
London, SE1 9RT, United Kingdom
Novartis Investigative Site
Manchester, M20 9BX, United Kingdom
Novartis Investigative Site
Sheffield, S10 2SJ, United Kingdom
Related Publications (1)
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.
PMID: 29242283DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Trial terminated based on the results of a pre-planned interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus)..The secondary OM analyses were not conducted
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 27, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 7, 2016
Results First Posted
April 7, 2016
Record last verified: 2016-03