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Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

Phase 2
18 Years
Open (Enrolling)
Pancreatic Neuroendocrine Tumors (pNET)

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Trial Information

Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

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 8 weeks after randomisation

Outcome Time Frame:

up to approx. 18 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

March 2016

Related Keywords:

  • Pancreatic Neuroendocrine Tumors (pNET)
  • Pancreatic
  • Neuroendocrine tumors
  • PNET
  • BEZ235
  • Everolimus
  • Neuroectodermal Tumors, Primitive
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



Northwestern University Chicago, Illinois  60611
Dana Farber Cancer Institute SC-6 Boston, Massachusetts  02115
Cedars Sinai Medical Center SC-3 Los Angeles, California  90048
MD Anderson Cancer Center/University of Texas Gastrointestinal Med. Oncology Houston, Texas  77030-4009
University of Texas Southwestern Medical Center UTSW 4 Dallas, Texas  75390-8527
University of California at Los Angeles Santa Monica Location Los Angeles, California  90095
University of Colorado Univ Colorado Aurora, Colorado  80045
H. Lee Moffitt Cancer Center/University of South Florida H Lee Moffitt 2 Tampa, Florida  33612
University of Kentucky Univ Kebtucky Lexington, Kentucky  40536-0098
Montefiore Medical Center SC Bronx, New York  10467
University of Pittsburgh Cancer Institute SC Pittsburgh, Pennsylvania  15232