A Multicenter, Two Stage, Phase II Study, Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Stage 1 - Progression Free Survival (PFS) at 16 weeks
Stage 1 Progression Free Survival is defined as the number of progression free patients divided by the total number of patients in the full analysis set. PFS will be assessed according to local radiological assessment per modified RECIST v1.1
16 weeks after the first BEZ235 administration.
United States: Food and Drug Administration
|Dana Farber Cancer Institute SC||Boston, Massachusetts 02115|
|Oregon Health & Science University Knight Cancer Institute||Portland, Oregon 97239|
|Ohio State Comprehensive Cancer Center/James Cancer Hospital SC||Columbus, Ohio 43210|
|Montefiore Medical Center SC-2||Bronx, New York 10467|
|Indiana University SC||Indianapolis, Indiana 46202|