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
NCT ID: NCT04083235
Last Updated: 2025-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
770 participants
INTERVENTIONAL
2020-02-11
2025-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
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.
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.
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.
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).
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.
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.
Interventions
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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).
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.
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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health- MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
University of California- Irvine Health Cancer Cente
Costa Mesa, California, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Torrance Memorial Physician Network Cancer Care
Redondo Beach, California, United States
Sutter Health Sacramento
Sacramento, California, United States
Presbyterian Intercommunity Hospital (PIH)
Whittier, California, United States
UC Health Memorial Hospital
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Miami Cancer Institute
Miami, Florida, United States
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, United States
Florida Cancer Specialists - Fort Myers
Sarasota, Florida, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
Florida Cancer Specialists - St. Petersburg
Tampa, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Edward Hospital - Elmhurst
Elmhurst, Illinois, United States
Illinois CancerCare - Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Siouxland Hematology - Oncology Associates, LLP
Sioux City, Iowa, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Health Partners Institute
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Frontier Cancer Center
Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Clinical Research Alliance, Inc
Lake Success, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, United States
Kaiser Permanente - Northwest
Portland, Oregon, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Chattanooga Oncology Hematology Care - Tennessee Oncology
Chattanooga, Tennessee, United States
The West Cancer Center
Memphis, Tennessee, United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology - Wichita Falls
Wichita Falls, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Wytheville, Virginia, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital
Bankstown, , Australia
Monash Medical Centre
Clayton, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
St John of God Subiaco Hospital
Subiaco, , Australia
Queen Elizabeth Hospital
Woodville South, , Australia
Medizinische Universitaet Graz
Graz, , Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, , Austria
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
Salzburg, , Austria
Medical University of Vienna
Vienna, , Austria
Onze-Lieve-Vrouwziekenhuis
Aalst, , Belgium
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, , Belgium
University Hospital Gent
Ghent, , Belgium
Hospital centre Jolimont
Haine-Saint-Paul, , Belgium
University Hospital (UZ) Leuven
Leuven, , Belgium
University Hospital Mont-Godinne
Yvoir, , Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, , Brazil
Centro Regional Integrado de Oncologia (CRIO)
Ceará, , Brazil
Instituto de Oncologia do Parana - IOP
Curitiba, , Brazil
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, , Brazil
Hospital de Caridade de Ijui
Ijuí, , Brazil
Clinica Neoplasias Litoral
Itajaí, , Brazil
Hospital Bruno Born
Lajeado, , Brazil
Centro de Pesquisas Clinicas de Natal - CPCLIN
Natal, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Instituto Nacional Do Cancer (INCA)
Rio de Janeiro, , Brazil
Instituto COI
Rio de Janeiro, , Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base
São José do Rio Preto, , Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, , Brazil
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
São Paulo, , Brazil
Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, , Brazil
Alberta Health Services Cross Cancer Institute
Edmonton, , Canada
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
McGill University Faculty of Medicine - Royal Victoria Hospital
Montreal, , Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, , Canada
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
University Hospital Olomouc, Department of Oncology
Olomouc, , Czechia
Thomayerova Nemocnice
Prague, , Czechia
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Centre Oscar Lambret
Lille, , France
Hôpital Edouard Herriot
Lyon, , France
Centre Leon Berard
Lyon, , France
Hopital Prive Jean Mermoz
Lyon, , France
Centre Antoine-Lacassagne
Nice, , France
Hopital Saint Louis
Paris, , France
CHU Bordeaux - Hopital Haut-Leveque
Pessac, , France
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
Poitiers, , France
Strasbourg Oncologie Liberale
Strasbourg, , France
Charité - Universitaetsmedizin Berlin
Berlin, , Germany
St. Josef-Hospital
Bochum, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
Studiengesellschaft BSF
Halle, , Germany
Martin Luther Universitat Halle-Wittenberg
Halle, , Germany
Facharztzentrum Eppendorf
Hamburg, , Germany
Marienkrankenhaus Hamburg
Hamburg, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Slk-Kliniken
Heilbronn, , Germany
Klinikum Mannheim
Mannheim, , Germany
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
Mönchengladbach, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Agios Savvas Anticancer Hospital
Athens, , Greece
General Hospital of Athens - Laiko
Athens, , Greece
National and Kapodistrian University of Athens
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
Theagenion Hospital
Thessaloniki, , Greece
Dél-pesti Centrumkórház - Szent László Kórház telephely
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
Szolnok, , Hungary
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
Piacenza, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
AOU Ospedali Riuniti di Ancona
Torrette, , Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, , Italy
Hospital de Braga
Braga, , Portugal
Champalimaud Cancer Center
Lisbon, , Portugal
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
Senhora da Hora, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
Vila Nova de Gaia, , Portugal
Evimed LLC
Chelyabinsk, , Russia
Limited Liability Company- Clinica Druzhkovyh
Kazan', , Russia
Kursk Regional Clinical Oncology Dispensary
Kursk, , Russia
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, , Russia
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
Saint Petersburg, , Russia
Volga District Medical Centre
Veliky Novgorod, , Russia
Inje University Haeundae Paik Hospital
Busan, , South Korea
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital General Universitario de Elche
Alicante, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, , Spain
Hospital Vall D Hebron
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Guy's and St. Thomas' NHS Foundation Trust
London, , United Kingdom
Royal Marsden Foundation Trust
London, , United Kingdom
Royal Marsden Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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References
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Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003585-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-US-60010-001
Identifier Type: -
Identifier Source: org_study_id
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