BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Pancreatic Neuroendocrine Tumors (pNET)
Interventions
DRUG

BEZ235 (Stage 1)

The investigational study drug used in this trial was BEZ235, which was supplied as 50mg, 200mg, 300mg, and 400mg solid dispersion sachets. Supply as 200mg and 50mg were provided for dose reduction. Patients were instructed to take the contents of one sachet of BEZ235 twice a day in the morning within 30 minutes after a light meal (breakfast).

Trial Locations (17)

3000

Novartis Investigative Site, Leuven

10467

Montefiore Medical Center SC-2, The Bronx

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

28041

Novartis Investigative Site, Madrid

43210

Ohio State Comprehensive Cancer Center/James Cancer Hospital SC, Columbus

45147

Novartis Investigative Site, Essen

46202

Indiana University SC, Indianapolis

50134

Novartis Investigative Site, Florence

69437

Novartis Investigative Site, Lyon

94805

Novartis Investigative Site, Villejuif

02215

Dana Farber Cancer Institute GastrointestionalCancer Clinic, Boston

A-1090

Novartis Investigative Site, Vienna

3015 CE

Novartis Investigative Site, Rotterdam

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

M20 4BX

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY