A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (nal-IRI)-containing Regimens versus nab-Paclitaxel plus Gemcitabine in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

The study is divided into two parts:
Part 1:To evaluate the safety and tolerability of nal-IRI + 5FU/LV +
oxaliplatin. To characterize dose-limiting toxicities (DLTs) associated with nal-IRI + 5FU/LV + oxaliplatin and determine the Part 2 dose of the
triplet combination.
Part 2:To assess the efficacy of nal-IRI-containing regimens in first-line
metastatic pancreatic cancer patients compared to nab-paclitaxel +
gemcitabine using the progression-free survival (PFS) rate at 24 weeks.

Study Number: 

PH 276815

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.