Overview

Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Status:
Completed

Trial end date:
2021-06-28

Target enrollment:

Participant gender:

Summary

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 not previously treated for metastatic pancreatic adenocarcinoma. 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

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Ipsen
Merrimack Pharmaceuticals

Treatments:

Albumin-Bound Paclitaxel
Fluorouracil
Gemcitabine
Irinotecan
Leucovorin
Oxaliplatin
Paclitaxel