Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is less
than 5 %. Since the introduction of gemcitabine, further advances in therapy in the
advanced/metastatic setting have been extremely slow. Numerous phase III studies have
evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any
observed benefits have been small and restricted to patients with a good performance status
(PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine +
nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine alone.
Nab-paclitaxel is especially interesting because it is able to break-down the tumor matrix
and increases the concentration of cytotoxic drugs in the tumor.
Our study will explore the modification of the desmoplastic reaction seen in pancreatic
cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog
inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)