A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01911416|
Recruitment Status : Withdrawn (No accrual)
First Posted : July 30, 2013
Last Update Posted : June 9, 2016
Pancreatic cancer is considered a rare form of cancer with about 277,000 new cases diagnosed in 2008 world-wide, which is about 2.5% of all forms of cancer. However, pancreatic cancer is more common in developed countries where the rate of this tumor is on the rise compared to other types of cancer.
LDE225 is a new medicine that blocks a cellular pathway (called Hedgehog pathway) that is thought to be changed in some patients with pancreatic cancer. LDE225 is a medicine which has not been approved by the FDA for the treatment of people with your medical condition. The medicine being tested in this study is currently not "on the market" (available to buy) in any country.
The purpose of this study is to see the effect LDE225 has on blood and tumors.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Drug: LDE225||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: All participants
All participants on study
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 36 months ]Correlation between plasma and tumour concentrations of LDE225
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911416
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States|
|Principal Investigator:||Ignacio Garrido-Laguna, MD||Huntsman Cancer Institute|