A randomized, open-label phase II study of nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (mPAC).
2016
TPS482 Background: Two combination
chemotherapy regimenshave emerged as standard of care options for first-line treatment of mPAC: 5-fluorouracil (5-FU)/leucovorin (LV) +
irinotecan+
oxaliplatin(
FOLFIRINOX), and
nab-paclitaxel+
gemcitabine. Nal-IRI (MM-398) is a nanoliposomal formulation of
irinotecan. In a randomized phase 3 study (NAPOLI-1), of patients with mPAC who had been previously treated with
gemcitabine-based therapy, nal-IRI + 5-FU/LV demonstrated its safety and significant clinical activity, increasing overall survival (OS) and progression-free survival (PFS) relative to 5-FU/LV. The goal of this current study is to determine the preliminary safety and efficacy of nal-IRI+ + 5-FU/LV with or without
oxaliplatinas compared to
nab-paclitaxel+
gemcitabinein previously untreated patients with mPAC. Methods: This open-label, phase 2 comparative study will be conducted in two parts. Part 1 is a safety run-in of a nal-IRI+5-FU/LV +
oxaliplatinregimen. The safety run-in will enroll small cohort...
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