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

Investigator: Maen Abdelrahim, MD

Study Coordinator: Denesha Potts

Status: Enrolling

ClinicalTrials.gov Number: NCT02551991

Phone: 713.441.6011

Protocol Number: Pro00019601

Description

This is an open-label, phase 2 comparative study to assess the safety, tolerability, and preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy. This study will assess the following regimen: • nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin The study will be conducted in two parts: 1.Part 1a: a safety run-in as initial dose exploration 2.Part 1b: dose expansion of the nal-IRI + 5FU/LV + oxaliplatin regimen
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