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
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To determine the maximal tolerated doses of LDE225 in combination with FOLFIRINOX in patients with locally advanced or metastatic pancreatic adenocarcinoma
2 years
Yes
Eunice Kwak, MD, PhD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
11-164
NCT01485744
December 2011
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |