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)

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: Active, not recruiting
• Conditions: Metastatic Adenocarcinoma of the Pancreas
• Intervention / Treatment: Drug: Irinotecan Liposomal Injection; Drug: Oxaliplatin; Drug: 5Fluorouracil; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 770
• Phase: Phase 3

Contacts and Locations

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)
  • Gent, 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
    • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Ceara, 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 Oncológicas - CEPON
  • Ijuí, Brazil, 98700
    • Hospital de Caridade de Ijui
  • Itajaí, Brazil, 88301-220
    • Clinica 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 Misericórdia de Porto Alegre
  • Rio De Janeiro, Brazil, 22793-080
    • Instituto Coi
  • Rio de Janeiro, Brazil, 20230-130
    • Instituto Nacional Do Cancer (INCA)
  • San Paolo, Brazil, 03102-006
    • Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
  • 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 São Paulo (ICESP)
• Canada
  • Edmonton, Canada, T6G 1Z2
    • Alberta Health Services Cross Cancer Institute
  • Halifax, Canada, B3H 3A7
    • Queen Elizabeth II Health Sciences Centre
  • Montréal, 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
  • Praha, 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
    • Hopital Prive Jean Mermoz
  • Nice, France, 06189
    • Centre Antoine-Lacassagne
  • Paris, France, 75010
    • Hôpital Saint Louis
  • Pessac, France, 33604
    • CHU Bordeaux - Hopital Haut-Leveque
  • Poitiers Cedex, France, 86021
    • Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
  • Strasbourg, France, 67000
    • Strasbourg Oncologie Libérale
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin
  • Bochum, Germany, 44791
    • St. Josef-Hospital
  • Esslingen, 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
  • Hannover, 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
  • Tuebingen, 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
  • Ioánnina, Greece, 45500
    • University General Hospital of Ioannina
  • Thessaloníki, 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 Belgyogyaszati es Hematologiai Klinika
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház
  • Szolnok, Hungary, H-5000
    • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
• Israel
  • Beer Sheva, 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
  • Milano, 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
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Goyang-si, Korea, Republic of, 10408
    • National Cancer Center
  • Gyeonggi-do, Korea, Republic of, 13520
    • CHA Bundang Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital, The Catholic University of Korea
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
  • Lisbon, Portugal, 1400-038
    • Champalimaud Cancer Center
  • 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
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Evimed LLC
  • Kazan, Russian Federation, 420126
    • Limited Liability Company- Clinica Druzhkovyh
  • Kursk, Russian Federation, 305524
    • Kursk Regional Clinical Oncology Dispensary
  • Moscow, Russian Federation, 105229
    • Main Military Clinical Hospital named after N.N. Burdenko
  • Novgorod, Russian Federation, 603074
    • Volga District Medical Centre
  • Saint-Petersburg, Russian Federation
    • Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
• 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
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28050
    • Centro Integral Oncológico Clara Campal
  • Málaga, Spain, 29009
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Santander, Spain, 39008
    • Hospital Universitario Marques 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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 DCO date of 23 July 2022 (maximum of 893 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit (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.	Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit, (maximum of 893 days)

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): July 23, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Paclitaxel; Fluorouracil; Oxaliplatin; Leucovorin; Irinotecan; Gemcitabine
• Other Study ID Numbers: D-US-60010-001; 2018-003585-14 (EudraCT Number)

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 US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No