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 (NAPOLI 3)

April 17, 2026 updated by: Ipsen

An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
770

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bankstown, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Clayton, Australia, 3168
        • Monash Medical Centre
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Subiaco, Australia, 6008
        • St John of God Subiaco Hospital
      • Woodville South, Australia, 5011
        • Queen Elizabeth Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Salzburg, Austria, A-5020
        • SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis
      • Charleroi, Belgium, 6000
        • ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen (UZA)
      • Ghent, Belgium, 9000
        • University Hospital Gent
      • Haine-Saint-Paul, Belgium, 7100
        • Hospital centre Jolimont
      • Leuven, Belgium, 3000
        • University Hospital (UZ) Leuven
      • Yvoir, Belgium, 5530
        • University Hospital Mont-Godinne
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
      • Ceará, Brazil, 60336-550
        • Centro Regional Integrado de Oncologia (CRIO)
      • Curitiba, Brazil, 80530-010
        • Instituto de Oncologia do Parana - IOP
      • Florianópolis, Brazil, 88034-000
        • Centro de Pesquisas Oncologicas - CEPON
      • Ijuí, Brazil, 98700
        • Hospital de Caridade de Ijui
      • Itajaí, Brazil, 88301-220
        • Clínica Neoplasias Litoral
      • Lajeado, Brazil, 95900
        • Hospital Bruno Born
      • Natal, Brazil, 59025-050
        • Centro de Pesquisas Clinicas de Natal - CPCLIN
      • Porto Alegre, Brazil
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
      • Rio de Janeiro, Brazil, 22793-080
        • Instituto Coi
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional Do Cancer (INCA)
      • São José do Rio Preto, Brazil, 5416
        • CIP Centro Integrado de Pesquisas do Hospital de Base
      • São Paulo, Brazil, 01323-001
        • Hospital Alemao Oswaldo Cruz
      • São Paulo, Brazil
        • Instituto do Cancer do Estado de Sao Paulo (ICESP)
      • São Paulo, Brazil, 03102-006
        • Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
  • Canada
      • Edmonton, Canada, T6G 1Z2
        • Alberta Health Services Cross Cancer Institute
      • Halifax, Canada, B3H 3A7
        • Queen Elizabeth II Health Sciences Centre
      • Montreal, Canada, H3G 1Y6
        • McGill University Faculty of Medicine - Royal Victoria Hospital
      • Sherbrooke, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
  • Czechia
      • Brno, Czechia, 65653
        • Masarykuv onkologicky ustav
      • Hradec Králové, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 77020
        • University Hospital Olomouc, Department of Oncology
      • Prague, Czechia, 14059
        • Thomayerova nemocnice
  • France
      • Chambray-lès-Tours, France, 37170
        • CHRU de Tours - Hopital Trousseau
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69003
        • Hôpital Edouard Herriot
      • Lyon, France, 69008
        • Hôpital Privé Jean Mermoz
      • Nice, France, 06189
        • Centre Antoine-Lacassagne
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pessac, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
      • Strasbourg, France, 67000
        • Strasbourg Oncologie Libérale
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitaetsmedizin Berlin
      • Bochum, Germany, 44791
        • St. Josef-Hospital
      • Esslingen am Neckar, Germany, 73730
        • Klinikum Esslingen GmbH
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest
      • Halle, Germany, 06108
        • Studiengesellschaft BSF
      • Halle, Germany, 06120
        • Martin Luther Universitat Halle-Wittenberg
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf
      • Hamburg, Germany, 22087
        • Marienkrankenhaus Hamburg
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heilbronn, Germany, 74078
        • Slk-Kliniken
      • Mannheim, Germany, 68167
        • Klinikum Mannheim
      • Mönchengladbach, Germany, 41063
        • Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Greece
      • Athens, Greece, 11522
        • Agios Savvas Anticancer Hospital
      • Athens, Greece, 11528
        • General Hospital of Athens - Laiko
      • Athens, Greece, 11528
        • National and Kapodistrian University of Athens
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina
      • Thessaloniki, Greece, 54007
        • Theagenion Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1097
        • Dél-pesti Centrumkórház - Szent László Kórház telephely
      • Budapest, Hungary, H-1089
        • Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Szolnok, Hungary, H-5000
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
  • Israel
      • Beersheba, Israel, Beer Sheva
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola-Malpighi
      • Meldola, Italy, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena
      • Piacenza, Italy, 29121
        • AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Torrette, Italy, 60126
        • AOU Ospedali Riuniti di Ancona
      • Verona, Italy, 37134
        • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisbon, Portugal, 1400-038
        • Champalimaud Cancer Center
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
      • Senhora da Hora, Portugal, 4464-513
        • Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
  • Russia
      • Chelyabinsk, Russia, 454048
        • Evimed Llc
      • Kazan', Russia, 420126
        • Limited Liability Company- Clinica Druzhkovyh
      • Kursk, Russia, 305524
        • Kursk Regional Clinical Oncology Dispensary
      • Moscow, Russia, 105229
        • Main Military Clinical Hospital named after N.N. Burdenko
      • Saint Petersburg, Russia
        • Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
      • Veliky Novgorod, Russia, 603074
        • Volga District Medical Centre
  • South Korea
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Gyeonggi-do, South Korea, 13520
        • CHA Bundang Medical Center
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Spain
      • Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Badajoz, Spain, 06080
        • Hospital Universitario de Badajoz
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall D Hebron
      • Barcelona, Spain, 08023
        • Hospital Quironsalud Barcelona
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau Barcelona
      • Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
      • Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet
      • Granada, Spain, 18014
        • Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Málaga, Spain, 29009
        • Hospital Regional Universitario de Malaga
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' NHS Foundation Trust
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Foundation Trust
      • London, United Kingdom, SM2 5PT
        • Royal Marsden Foundation Trust
      • Manchester, United Kingdom, M20 4BX
        • Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner Health- MD Anderson Cancer Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Scottsdale
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Costa Mesa, California, United States, 92627
        • University of California- Irvine Health Cancer Cente
      • Duarte, California, United States, 91010
        • City Of Hope National Medical Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA)
      • Orange, California, United States, 92868
        • University of California - Irvine Medical Center
      • Orange, California, United States, 92835
        • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
      • Redondo Beach, California, United States, 90277
        • Torrance Memorial Physician Network Cancer Care
      • Sacramento, California, United States, 95816
        • Sutter Health Sacramento
      • Whittier, California, United States, 90602
        • Presbyterian Intercommunity Hospital (PIH)
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • UC Health Memorial Hospital
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center of Florida, Inc.
      • Sarasota, Florida, United States, 34236
        • Florida Cancer Specialists - Fort Myers
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists - Panhandle
      • Tampa, Florida, United States, 33607
        • Florida Cancer Specialists - St. Petersburg
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists - East
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Elmhurst, Illinois, United States, 60540
        • Edward Hospital - Elmhurst
      • Peoria, Illinois, United States, 61443
        • Illinois CancerCare - Peoria
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology - Oncology Associates, LLP
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center
      • Pikeville, Kentucky, United States, 41501
        • Pikeville Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71103
        • Willis-Knighton Cancer Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center For Cancer Medicine
    • Maryland
      • Silver Spring, Maryland, United States, 20904
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49546
        • Cancer and Hematology Centers of Western Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55425
        • Health Partners Institute
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic - Rochester
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • Montana
      • Billings, Montana, United States, 59102
        • Frontier Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Lake Success, New York, United States, 10021
        • Clinical Research Alliance, Inc
      • New York, New York, United States, 10065
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Messino Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma - Health Sciences Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
      • Portland, Oregon, United States, 97227
        • Compass Oncology - Rose Quarter Cancer Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente - Northwest
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Care - Tennessee Oncology
      • Memphis, Tennessee, United States, 38138
        • The West Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon and HCA Research Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
      • Houston, Texas, United States, 77030
        • Oncology Consultants
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology - Wichita Falls
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Wytheville, Virginia, United States, 24014
        • Blue Ridge Cancer Care
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
  • Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.
  • Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.
  • Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).
  • Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.
  • Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).

Exclusion Criteria:

  • Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
  • Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
  • Subject has only localised advanced disease.
  • Documented serum albumin <3 g/dL
  • Known history of central nervous system (CNS) metastases.
  • Clinically significant gastrointestinal disorder
  • History of any second malignancy in the last 2 years
  • Concurrent illnesses that would be a relative contraindication to trial participation
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
  • Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
  • Known low or absent dihydropyrimidine dehydrogenase (DPD) activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Drug: Irinotecan Liposomal Injection
Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).
Other Names:
  • Nal-IRI
  • Onivyde®
Drug: Oxaliplatin
Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
Other Names:
  • Eloxatin®
Drug: 5Fluorouracil
Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.
Other Names:
  • 5-FU
  • Adrucil®
  • flurouracil
Drug: Leucovorin
Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
Other Names:
  • Folinic Acid
Active Comparator: Nab-paclitaxel + Gemcitabine
Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Drug: Nab-paclitaxel
Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
Other Names:
  • Abraxane®
Drug: Gemcitabine
Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.
Other Names:
  • Gemzar®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)
The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days)
PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.
Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days)
Overall Response Rate (ORR)
Time Frame: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)
The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ipsen Medical Director, Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D-US-60010-001
  • 2018-003585-14 (EudraCT Number)
  • 2024-518303-21-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD Sharing Time Frame

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the United States (US) and/or Europe (EU).

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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