Irinotecan Liposomal Injection

DRUG3 trials

Conditions

Metastatic Adenocarcinoma of the PancreasMetastatic Pancreatic Cancer

Phase 2

Ludwig-Maximilians - University of MunichMetastatic Pancreatic Cancer

Start: 2019-02-15End: 2023-07-31Updated: 2022-09-08

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

CompletedNCT03693677

Federation Francophone de Cancerologie DigestiveMetastatic Pancreatic Cancer

Start: 2018-11-16End: 2025-01-10Updated: 2025-07-01

Phase 3

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

CompletedNCT04083235

IpsenMetastatic Adenocarcinoma of the Pancreas

Start: 2020-02-11End: 2025-02-18Updated: 2026-03-09

2025-08-05

NAPOLI 3, a phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final overall survival (OS) analysis and characteristics of the long-term survivors.

Journal of Clinical Oncology2025-06-042 citations

5-FU + Naliri, gemcitabine plus nab-paclitaxel or both regimens given sequentially for first line treatment of metastatic pancreatic ductal adenocarcinoma: A randomized phase II comparative study (FUNGEMAX-PRODIGE 61).

Journal of Clinical Oncology2025-05-281 citations

Overall survival (OS) with NALIRIFOX (NFX) compared to FOLFIRINOX (FFX) in patients not previously treated for metastatic pancreatic ductal adenocarcinoma (mPDAC): An external control arm study.

Journal of Clinical Oncology2025-05-28

NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design

Future Oncology2025-02-22

Overall survival (OS) of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with first-line (1L) FOLFIRINOX (FFX): Bridging the gap between the NAPOLI 3 trial and real-world practice.

Journal of Clinical Oncology2025-01-271 citations

Impact of <i>UGT1A1*28</i> polymorphism on tolerability in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX in NAPOLI 3.

Journal of Clinical Oncology2025-01-271 citations

Effect of dose adjustments on overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX: A post hoc analysis of NAPOLI 3.

Journal of Clinical Oncology2025-01-27

Randomized phase 2 study of valproic acid combined with simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic pancreatic adenocarcinoma patients: the VESPA trial study protocol.

2024-09-195 citations

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3.

Journal of Clinical Oncology2024-06-012 citations

Kinetics of CA19-9 decline in a randomized phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracial/leucovorin (NALIRIFOX) or nab-paclitaxel plus gemcitabine (GEM+NABP) in patients who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas (NAPOLI 3).

Journal of Clinical Oncology2024-01-201 citations

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.

2023-09-11295 citations

FOOTPATH: A randomized, open-label phase-2 study of liposomal irinotecan + 5-FU and folinic acid (NAPOLI) versus sequential NAPOLI and mFOLFOX6 versus gemcitabine/nab-paclitaxel in treatment-naïve metastatic pancreatic cancer (mPDAC).

Journal of Clinical Oncology2023-06-016 citations

Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3 trial.

Journal of Clinical Oncology2023-06-013 citations

NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2023-01-2466 citations

Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer

CPT Pharmacometrics & Systems Pharmacology2021-11-0911 citations

NAPOLI-3: An open-label, randomized, phase III study of first-line liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin versus nab-paclitaxel + gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

Journal of Clinical Oncology2020-05-2010 citations

Irinotecan Liposomal Injection

Sponsors

Conditions

Phase 2

Phase 3

Related Papers