A Pilot Study of a Hedgehog Pathway Inhibitor (LDE-225) in Surgically Resectable Pancreas Cancer
We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result in inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no effect on autocrine signaling in the tumor cell compartment. Furthermore we hypothesize that treatment with LDE-225 will result in changes in the tumor stroma (decreased desmoplasia, increased vascularity) that will result in improved tumor blood flow.
The purpose of this study is to determine if, where and how LDE-225 works in pancreatic cancer. A cancer cell's growth can depend on the cells and tissue around it. The cells and tissue make chemical signals to influence the cancer's growth. This research study is evaluating LDE-225 designed to interfere with one of the growth signals causing pancreatic cancer growth.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of a Hedgehog Pathway Inhibitor (LDE-225) in Surgically Resectable Pancreas Cancer|
- Changes in mean Gli-1 levels before and after drug [ Time Frame: 2 years ] [ Designated as safety issue: No ]Means and variances of the (transformed) data for samples from stroma and tumor are calculated. Data is collected from patients in pairs (with the first observation from the biopsy prior to drug and the second after surgery, and after the drug), and it is expected these two observations will be correlated. Detectable differences for a range of four correlations will be computed.
- Complications from surgery by time of hospital discharge up to 30 days post-operatively [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
LDE-225: dose - 800 mg, taken by mouth once daily for 2 weeks.
LDE-225 capsules will be administered as a fixed dose of 800 mg daily for two weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694589
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Darren Carpizo, MD, PhD||Rutgers Cancer Institute of New Jersey|