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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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
CT

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
weeks

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

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:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235Z2401

NCT ID:

NCT01628913

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

Name

Location

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