Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b Clinical Trial of LDE225 in Combination With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) in Previously Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma, With an Expansion Cohort at the Recommended Phase 2 Dose
LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade of molecular events that control cell growth and have been linked with the development of many human cancers, including pancreatic cancer. Information from research studies suggests that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In this research study, the investigators are looking to determine the maximum dose of LDE225 in combination that can be given safely to patients with locally advanced or metastatic pancreatic cancer.
Study medication will be given in cycles of 14 days. Subjects will keep a study drug diary
for each treatment cycle. LDE225 capsules will be taken by mouth in the morning every day of
each cycle.
On days 1-2 of each cycle, subjects will take LDE225 at the clinic followed by FOLFIRINOX
intravenous infusion (through a vein).
Subjects will come to the clinic weekly for the first 5 weeks, then every other week (Week 7,
9, 11, etc.) and receive the following procedures:
Review of current medications and any side effects Physical exam Performance Status Blood
tests (2 teaspoons of blood) Assessment of tumor (repeated every 8 weeks) ECG at week 3 and 5
Subjects will also have pharmacokinetic (PK) blood samples taken. PK samples are used to find
out the amount of study medication in the blood. Each PK sample is about 1/2 teaspoon of
blood. Subjects will have PK samples taken on:
Day 1 of Cycles 1, 2, 3, 4, 6, and 7 before the dose of LDE225 Day 1 of Cycle 5 - drawn
before the first dose of LDE225 and at 1, 2, 3, 4, 5, and 6 hours Day 2 of Cycle 5: One PK
blood sample
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