Metastatic Adenocarcinoma of the PancreasPhase 3NAPOLI 3NCT04083235
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
A Phase 3 study testing Irinotecan Liposomal Injection, Oxaliplatin and 5Fluorouracil in people with Metastatic Adenocarcinoma of the Pancreas, run by Ipsen at 200 sites in 18 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Adenocarcinoma of the Pancreas
- What is being tested?
- Irinotecan Liposomal Injection, Oxaliplatin and 5Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 200 sitesin 18 countries
- Study dates
- 11 Feb 2020to 18 Feb 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ).
Who cannot join
- 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
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- 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
Trial locations and contacts
200 sites in 18 countries.
200 sites in 18 countries
United States72 sites
Messino Cancer Center
Asheville, North Carolina, 28806
Texas Oncology - Austin
Austin, Texas, 78731
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess
Boston, Massachusetts, 02215
Chattanooga Oncology Hematology Care - Tennessee Oncology
Chattanooga, Tennessee, 37404
Rush University Medical Center
Chicago, Illinois, 60612
UC Health Memorial Hospital
Colorado Springs, Colorado, 80909
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus, Ohio, 43210
University of California- Irvine Health Cancer Cente
Costa Mesa, California, 92627
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
Edward Hospital - Elmhurst
Elmhurst, Illinois, 60540
Oncology Associates of Oregon
Eugene, Oregon, 97401
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Banner Health- MD Anderson Cancer Center
Gilbert, Arizona, 85234
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
Greenville Hospital System
Greenville, South Carolina, 29605
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Research Institute
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Oncology Consultants
Houston, Texas, 77030
Research Medical Center
Kansas City, Missouri, 64132
Clinical Research Alliance, Inc
Lake Success, New York, 10021
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
The West Cancer Center
Memphis, Tennessee, 38138
Miami Cancer Institute
Miami, Florida, 33176
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, 33140
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Health Partners Institute
Minneapolis, Minnesota, 55425
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, 73104
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, 92835
University of California - Irvine Medical Center
Orange, California, 92868
Illinois CancerCare - Peoria
Peoria, Illinois, 61443
Mayo Clinic - Scottsdale
Phoenix, Arizona, 85054
Pikeville Medical Center
Pikeville, Kentucky, 41501
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, 97227
Kaiser Permanente - Northwest
Portland, Oregon, 97227
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Torrance Memorial Physician Network Cancer Care
Redondo Beach, California, 90277
Mayo Clinic - Rochester
Rochester, Minnesota, 55902
University of Rochester
Rochester, New York, 14642
Sutter Health Sacramento
Sacramento, California, 95816
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Florida Cancer Specialists - Fort Myers
Sarasota, Florida, 34236
Maine Center for Cancer Medicine
Scarborough, Maine, 04074
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Maryland Oncology Hematology
Silver Spring, Maryland, 20904
Siouxland Hematology - Oncology Associates, LLP
Sioux City, Iowa, 51101
Stony Brook University Medical Center
Stony Brook, New York, 11794
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308
Florida Cancer Specialists - St. Petersburg
Tampa, Florida, 33607
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
Texas Oncology - Tyler
Tyler, Texas, 75702
Carle Cancer Center
Urbana, Illinois, 61801
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Presbyterian Intercommunity Hospital (PIH)
Whittier, California, 90602
Texas Oncology - Wichita Falls
Wichita Falls, Texas, 76310
Blue Ridge Cancer Care
Wytheville, Virginia, 24014
Spain19 sites
Hospital General Universitario de Elche
Alicante, 03203
Hospital Universitario de Badajoz
Badajoz, 06080
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 08026
Hospital Vall D Hebron
Barcelona, 08035
Hospital Clinic Barcelona
Barcelona, 08036
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Barcelona, 08208
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Centro Integral Oncologico Clara Campal
Madrid, 28050
Hospital Regional Universitario de Malaga
Málaga, 29009
Complejo Hospitalario de Navarra
Pamplona, 31008
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil15 sites
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784-400
Centro Regional Integrado de Oncologia (CRIO)
Ceará, 60336-550
Instituto de Oncologia do Parana - IOP
Curitiba, 80530-010
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, 88034-000
Hospital de Caridade de Ijui
Ijuí, 98700
Clinica Neoplasias Litoral
Itajaí, 88301-220
Hospital Bruno Born
Lajeado, 95900
Centro de Pesquisas Clinicas de Natal - CPCLIN
Natal, 59025-050
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Instituto Nacional Do Cancer (INCA)
Rio de Janeiro, 20230-130
Instituto COI
Rio de Janeiro, 22793-080
CIP Centro Integrado de Pesquisas do Hospital de Base
São José do Rio Preto, 5416
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-001
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
São Paulo, 03102-006
Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo
Germany15 sites
Charité - Universitaetsmedizin Berlin
Berlin, 10117
St. Josef-Hospital
Bochum, 44791
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Krankenhaus Nordwest
Frankfurt, 60488
Studiengesellschaft BSF
Halle, 06108
Martin Luther Universitat Halle-Wittenberg
Halle, 06120
Facharztzentrum Eppendorf
Hamburg, 20249
Marienkrankenhaus Hamburg
Hamburg, 22087
Asklepios Klinik Altona
Hamburg, 22763
Medizinische Hochschule Hannover
Hanover, 30625
Slk-Kliniken
Heilbronn, 74078
Klinikum Mannheim
Mannheim, 68167
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
Universitaetsklinikum Tuebingen
Tübingen, 72076
Universitaetsklinikum Ulm
Ulm, 89081
France10 sites
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Centre Oscar Lambret
Lille, 59020
Hôpital Edouard Herriot
Lyon, 69003
Centre Leon Berard
Lyon, 69008
Hopital Prive Jean Mermoz
Lyon, 69008
Centre Antoine-Lacassagne
Nice, 06189
Hopital Saint Louis
Paris, 75010
CHU Bordeaux - Hopital Haut-Leveque
Pessac, 33604
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
Poitiers, 86021
Strasbourg Oncologie Liberale
Strasbourg, 67000
Italy8 sites
Policlinico S. Orsola-Malpighi
Bologna, 40138
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, 47014
Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
Piacenza, 29121
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
AOU Ospedali Riuniti di Ancona
Torrette, 60126
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134
Belgium7 sites
Onze-Lieve-Vrouwziekenhuis
Aalst, 9300
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
Charleroi, 6000
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650
University Hospital Gent
Ghent, 9000
Hospital centre Jolimont
Haine-Saint-Paul, 7100
University Hospital (UZ) Leuven
Leuven, 3000
University Hospital Mont-Godinne
Yvoir, 5530
Australia6 sites
Bankstown-Lidcombe Hospital
Bankstown, 2200
Monash Medical Centre
Clayton, 3168
Fiona Stanley Hospital
Murdoch, 6150
Sir Charles Gairdner Hospital
Nedlands, 6009
St John of God Subiaco Hospital
Subiaco, 6008
Queen Elizabeth Hospital
Woodville South, 5011
Hungary6 sites
Dél-pesti Centrumkórház - Szent László Kórház telephely
Budapest, 1097
Országos Onkológiai Intézet
Budapest, 1122
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, H-1089
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
Szolnok, H-5000
Russia6 sites
Evimed LLC
Chelyabinsk, 454048
Limited Liability Company- Clinica Druzhkovyh
Kazan', 420126
Kursk Regional Clinical Oncology Dispensary
Kursk, 305524
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, 105229
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
Saint Petersburg
Volga District Medical Centre
Velikiy Novgorod, 603074
South Korea6 sites
Inje University Haeundae Paik Hospital
Busan, 48108
National Cancer Center
Goyang-si, 10408
CHA Bundang Medical Center
Gyeonggi-do, 13520
Asan Medical Center
Seoul, 05505
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
United Kingdom6 sites
Guy's and St. Thomas' NHS Foundation Trust
London, SE1 9RT
Royal Marsden Foundation Trust
London, SM2 5PT
Royal Marsden Foundation Trust
London, SW3 6JJ
Imperial College Healthcare NHS Trust
London, W12 0HS
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
Manchester, M20 4BX
Nottingham City Hospital
Nottingham, NG5 1PB
Greece5 sites
Agios Savvas Anticancer Hospital
Athens, 11522
General Hospital of Athens - Laiko
Athens, 11528
National and Kapodistrian University of Athens
Athens, 11528
University General Hospital of Ioannina
Ioannina, 45500
Theagenion Hospital
Thessaloniki, 54007
Portugal5 sites
Hospital de Braga
Braga, 4710-243
Champalimaud Cancer Center
Lisbon, 1400-038
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon, 1649-035
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
Senhora da Hora, 4464-513
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
Vila Nova de Gaia, 4434-502
Austria4 sites
Medizinische Universitaet Graz
Graz, 8036
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
Salzburg, A-5020
Medical University of Vienna
Vienna, 1090
Canada4 sites
Alberta Health Services Cross Cancer Institute
Edmonton, T6G 1Z2
Queen Elizabeth II Health Sciences Centre
Halifax, B3H 3A7
McGill University Faculty of Medicine - Royal Victoria Hospital
Montreal, H3G 1Y6
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, J1H 5N4
Czechia4 sites
Masarykuv onkologicky ustav
Brno, 65653
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
University Hospital Olomouc, Department of Oncology
Olomouc, 77020
Thomayerova Nemocnice
Prague, 14059
Israel2 sites
Soroka Medical Center
Beersheba, Beer Sheva
Rambam Health Care Campus
Haifa, 3109601
About this study
Official title: 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.
- Being tested
- Irinotecan Liposomal Injection, Oxaliplatin, 5Fluorouracil, Leucovorin, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Liposomal InjectionDrug
Also called Onivyde®, Nal-IRI
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).
OxaliplatinDrug
Also called Eloxatin®
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.
5FluorouracilDrug
Also called Adrucil®, flurouracil, 5-FU
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.
LeucovorinDrug
Also called Folinic Acid
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-paclitaxelDrug
Also called Abraxane®
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.
GemcitabineDrug
Also called Gemzar®
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.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome injection + Oxaliplatin + 5-FU/LV | Experimental | 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). Receives: Drug: Irinotecan Liposomal Injection; Drug: Oxaliplatin; Drug: 5Fluorouracil; Drug: Leucovorin |
| Nab-paclitaxel + Gemcitabine | Active comparator | Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity). Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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.
Measured: 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 outcomes (2)
Progression Free Survival (PFS)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start11 Feb 2020
- Primary completion23 Jul 2022
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083235
- Sponsor's protocol ID
- D-US-60010-001
- Other IDs
- 2018-003585-14, 2024-518303-21-00, 2018
- Acronym
- NAPOLI 3
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2019
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Abdelrahim M, Khan G, Hatoum H, Zervoudakis A, Dayyani F, Zhang L, Li J, Maxwell F, O'Reilly EM, Wainberg ZA, Bullock A. Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. Future Oncol. 2026 May;22(12):1421-1428. doi: 10.1080/14796694.2026.2664776. Epub 2026 May 4.
PubMed 42080361Wainberg 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.
PubMed 37708904