Protocol
12-036
Full Title
A Phase Ib, Open-label, Multi-center, Dose Escalation, Safety and Tolerability Study of LDE225 in Combination with Gemcitabine in Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Purpose
Gemcitabine is a chemotherapy drug commonly used to treat pancreatic cancer. However, more effective treatments are greatly needed. In this study, researchers want to find the highest dose of an investigational drug called LDE225 that can be given safely with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.
LDE225 works by inhibiting a cell signaling pathway called the Hedgehog pathway, which may be important for the growth of pancreatic cancer. It is a pill that is taken orally (by mouth).
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have locally advanced or metastatic pancreatic cancer.
- Patients involved in the dose escalation portion of the study may have had no prior therapy or must have disease that progressed despite prior chemotherapy. If patients had prior gemcitabine, it must have been completed at least a year before entering the study.
- Patients in the safety expansion portion of the study may not have had prior treatment within a year of study entry, but may have had gemcitabine more than a year prior.
- Patients in either portion of the study may not have had prior radiation therapy.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Kenneth Yu at 646-888-4188.
Disease(s)
Hepatobiliary: Pancreatic Cancer
Upper Gastrointestinal: Pancreatic Cancer
Locations
ClinicalTrials.gov
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