Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
Phase 1/2 Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma.
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.
The investigators propose treating 6-12 patients during the phase 1 portion and 40 patients
in the phase 2 stage.
Phase 1 Stage:
Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 in
combination with escalating doses (400mg, or 600mg, or 800mg) of LDE-225. After completion of
neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then
subjects who are eligible for resection will go ahead with surgery. Following resection,
subjects will complete two additional cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125
mg/m2 in combination with LDE-225.
Phase 2 Stage: In the Phase 2 stage the patients will be randomized to receive gemcitabine
and nab-paclitaxel with or without the hedgehog inhibitor LDE225:
1. Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8
and 15 in combination with LDE-225 at the recommended phase 2 dose.
2. Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8
and 15.
After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and
radiation. Then subjects who are eligible for resection will go ahead with surgery. Following
resection, subjects will complete two additional cycles of the pre-surgical therapy.
Several correlative laboratory studies will be conducted during the course of this study.
They were designed around the goals of providing us with a better understanding of how the
stroma-tumor interaction and the intra-tumoral drug levels of gemcitabine are affected with
the use of LDE-225. Two additional biopsies are required to participate in this study.
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