Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Pancreatic Cancer
Interventions
DRUG

LDE225+gemcitabine

Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle. Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment.

Trial Locations (5)

10021

Memorial Sloan Kettering Cancer Center MSKCC - SC, New York

84103

University of Utah / Huntsman Cancer Institute Huntsman UT, Salt Lake City

02114

Massachusetts General Hospital Dept. of Mass General Hospital, Boston

08035

Novartis Investigative Site, Barcelona

L7 8XP

Novartis Investigative Site, Liverpool

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY