Back to resultsA 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)
Primary Purpose
Metastatic Adenocarcinoma of the Pancreas
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irinotecan Liposomal Injection
Oxaliplatin
5Fluorouracil
Leucovorin
Nab-paclitaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Adenocarcinoma of the Pancreas
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- Banner Health- MD Anderson Cancer Center
- Mayo Clinic - Scottsdale
- Comprehensive Blood And Cancer Center
- University of California- Irvine Health Cancer Cente
- City of Hope National Medical Center
- University of California, Los Angeles (UCLA)
- St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
- University of California - Irvine Medical Center
- Torrance Memorial Physician Network Cancer Care
- Sutter Health Sacramento
- Presbyterian Intercommunity Hospital (PIH)
- UC Health Memorial Hospital
- Rocky Mountain Cancer Center
- Mount Sinai Medical Center of Florida, Inc.
- Miami Cancer Institute
- Florida Cancer Specialists - Fort Myers
- Florida Cancer Specialists - Panhandle
- Florida Cancer Specialists - St. Petersburg
- Florida Cancer Specialists - East
- Rush University Medical Center
- Edward Hospital - Elmhurst
- Illinois CancerCare - Peoria
- Carle Cancer Center
- Fort Wayne Medical Oncology and Hematology
- Siouxland Hematology - Oncology Associates, LLP
- University of Kentucky Markey Cancer Center
- Pikeville Medical Center
- Hematology Oncology Clinic
- Ochsner Clinic Foundation
- Willis-Knighton Cancer Center
- Maine Center for Cancer Medicine
- Maryland Oncology Hematology
- Beth Israel Deaconess
- Henry Ford Health System
- Cancer and Hematology Centers of Western Michigan
- Health Partners Institute
- Mayo Clinic - Rochester
- Research Medical Center
- Frontier Cancer Center
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists
- Comprehensive Cancer Centers of Nevada
- Clinical Research Alliance, Inc
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
- University of Rochester
- Stony Brook University Medical Center
- Messino Cancer Center
- The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
- Toledo Clinic Cancer Center
- University of Oklahoma - Health Sciences Center
- Oncology Associates of Oregon
- Compass Oncology - Rose Quarter Cancer Center
- Kaiser Permanente - Northwest
- Oregon Health & Science University (OHSU)
- University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
- Greenville Hospital System
- Chattanooga Oncology Hematology Care - Tennessee Oncology
- The West Cancer Center
- Sarah Cannon and HCA Research Institute
- Texas Oncology - Austin
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
- The Center for Cancer and Blood Disorders
- Baylor College of Medicine
- Houston Methodist Research Institute
- MD Anderson Cancer Center
- Oncology Consultants
- Texas Oncology - Tyler
- Texas Oncology - Wichita Falls
- Utah Cancer Specialists
- Virginia Cancer Specialists
- Blue Ridge Cancer Care
- Froedtert Hospital and the Medical College of Wisconsin
- Bankstown-Lidcombe Hospital
- Monash Medical Centre
- Fiona Stanley Hospital
- Sir Charles Gairdner Hospital
- St John of God Subiaco Hospital
- Queen Elizabeth Hospital
- Medizinische Universitaet Graz
- Ordensklinikum Linz GmbH Barmherzige Schwestern
- SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
- Medical University of Vienna
- Onze-Lieve-Vrouwziekenhuis
- ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
- Universitair Ziekenhuis Antwerpen (UZA)
- University Hospital Gent
- Hospital centre Jolimont
- University Hospital (UZ) Leuven
- University Hospital Mont-Godinne
- Fundação Pio XII - Hospital de Câncer de Barretos
- Centro Regional Integrado de Oncologia (CRIO)
- Instituto de Oncologia do Parana - IOP
- Centro de Pesquisas Oncológicas - CEPON
- Hospital de Caridade de Ijui
- Clinica Neoplasias Litoral
- Hospital Bruno Born
- Centro de Pesquisas Clinicas de Natal - CPCLIN
- Irmandade da Santa Casa de Misericordia de Porto Alegre
- Instituto Nacional Do Cancer (INCA)
- Instituto COI
- Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
- CIP Centro Integrado de Pesquisas do Hospital de Base
- Hospital Alemão Oswaldo Cruz
- Instituto do Cancer do Estado de São Paulo (ICESP)
- Alberta Health Services Cross Cancer Institute
- Queen Elizabeth II Health Sciences Centre
- McGill University Faculty of Medicine - Royal Victoria Hospital
- Centre Hospitalier Universitaire de Sherbrooke
- Masarykuv onkologicky ustav
- Fakultni nemocnice Hradec Kralove
- University Hospital Olomouc, Department of Oncology
- Thomayerova Nemocnice
- CHRU de Tours - Hôpital Trousseau
- Centre Oscar Lambret
- Hôpital Edouard Herriot
- Centre Leon Berard
- Hopital Prive Jean Mermoz
- Centre Antoine-Lacassagne
- Hopital Saint Louis
- CHU Bordeaux - Hopital Haut-Leveque
- Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
- Strasbourg Oncologie Liberale
- Charité - Universitaetsmedizin Berlin
- St. Josef-Hospital
- Klinikum Esslingen GmbH
- Krankenhaus Nordwest
- Studiengesellschaft BSF
- Martin Luther Universitat Halle-Wittenberg
- Facharztzentrum Eppendorf
- Marienkrankenhaus Hamburg
- Asklepios Klinik Altona
- Medizinische Hochschule Hannover
- Slk-Kliniken
- Klinikum Mannheim
- Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
- Universitaetsklinikum Tuebingen
- Universitaetsklinikum Ulm
- Agios Savvas Anticancer Hospital
- General Hospital of Athens - Laiko
- National and Kapodistrian University of Athens
- University General Hospital of Ioannina
- Theagenion Hospital
- Dél-pesti Centrumkórház - Szent László Kórház telephely
- Országos Onkológiai Intézet
- Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
- Debreceni Egyetem Klinikai Kozpont
- Somogy Megyei Kaposi Mor Oktato Korhaz
- Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
- Soroka Medical Center
- Rambam Health Care Campus
- Policlinico S. Orsola-Malpighi
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
- Istituto Europeo di Oncologia
- Azienda Ospedaliero-Universitaria di Modena
- AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
- Azienda Ospedaliero Universitaria Pisana
- AOU Ospedali Riuniti di Ancona
- Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
- Inje University Haeundae Paik Hospital
- National Cancer Center
- CHA Bundang Medical Center
- Asan Medical Center
- Seoul St. Mary's Hospital, The Catholic University of Korea
- Korea University Guro Hospital
- Hospital de Braga
- Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
- Champalimaud Cancer Center
- Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
- Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
- Evimed LLC
- Limited Liability Company- Clinica Druzhkovyh
- Kursk Regional Clinical Oncology Dispensary
- Main Military Clinical Hospital named after N.N. Burdenko
- Volga District Medical Centre
- Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
- Hospital General Universitario de Elche
- Hospital Universitario de Badajoz
- Hospital Germans Trias i Pujol
- Hospital Quironsalud Barcelona
- Hospital de la Santa Creu i Sant Pau Barcelona
- Hospital Vall D Hebron
- Hospital Clinic Barcelona
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
- Institut Catala d'Oncologia - L'Hospitalet
- Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
- Hospital General Universitario Gregorio Marañon
- Fundacion Jimenez Diaz
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Centro Integral Oncologico Clara Campal
- Hospital Regional Universitario de Malaga
- Complejo Hospitalario de Navarra
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario Miguel Servet
- Guy's and St. Thomas' NHS Foundation Trust
- Royal Marsden Foundation Trust
- Royal Marsden Foundation Trust
- Imperial College Healthcare NHS Trust
- Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
- Nottingham City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
Nab-paclitaxel + Gemcitabine
Arm Description
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).
Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Outcomes
Primary Outcome Measures
Overall survival (OS)
Secondary Outcome Measures
Progression free survival (PFS)
Overall Response Rate (ORR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04083235
Brief Title
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
Acronym
NAPOLI 3
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
July 23, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 not previously treated for metastatic pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Adenocarcinoma of the Pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
770 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
Arm Type
Experimental
Arm Description
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).
Arm Title
Nab-paclitaxel + Gemcitabine
Arm Type
Active Comparator
Arm Description
Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
Intervention Type
Drug
Intervention Name(s)
Irinotecan Liposomal Injection
Other Intervention Name(s)
Onivyde®, Nal-IRI
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5Fluorouracil
Other Intervention Name(s)
Adrucil®, flurouracil, 5-FU
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinic Acid
Intervention Description
Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Abraxane®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)
Title
Overall Response Rate (ORR)
Time Frame
From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner Health- MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Mayo Clinic - Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Comprehensive Blood And Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
University of California- Irvine Health Cancer Cente
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
City
Orange
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California - Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Torrance Memorial Physician Network Cancer Care
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Sutter Health Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Presbyterian Intercommunity Hospital (PIH)
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
UC Health Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Mount Sinai Medical Center of Florida, Inc.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists - St. Petersburg
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida Cancer Specialists - East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Edward Hospital - Elmhurst
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Illinois CancerCare - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Siouxland Hematology - Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Pikeville Medical Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Willis-Knighton Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Maine Center for Cancer Medicine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Maryland Oncology Hematology
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Beth Israel Deaconess
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Health Partners Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Clinical Research Alliance, Inc
City
Lake Success
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Messino Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
University of Oklahoma - Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Compass Oncology - Rose Quarter Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Kaiser Permanente - Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Chattanooga Oncology Hematology Care - Tennessee Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Sarah Cannon and HCA Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology - Wichita Falls
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Wytheville
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
ZIP/Postal Code
2200
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
St John of God Subiaco Hospital
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Onze-Lieve-Vrouwziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen (UZA)
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hospital centre Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
University Hospital (UZ) Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Centro Regional Integrado de Oncologia (CRIO)
City
Ceara
ZIP/Postal Code
60336-550
Country
Brazil
Facility Name
Instituto de Oncologia do Parana - IOP
City
Curitiba
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Centro de Pesquisas Oncológicas - CEPON
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital de Caridade de Ijui
City
Ijuí
ZIP/Postal Code
98700
Country
Brazil
Facility Name
Clinica Neoplasias Litoral
City
Itajaí
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital Bruno Born
City
Lajeado
ZIP/Postal Code
95900
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas de Natal - CPCLIN
City
Natal
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Instituto Nacional Do Cancer (INCA)
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Instituto COI
City
Rio De Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)
City
San Paolo
ZIP/Postal Code
03102-006
Country
Brazil
Facility Name
CIP Centro Integrado de Pesquisas do Hospital de Base
City
São José Do Rio Preto
ZIP/Postal Code
5416
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Instituto do Cancer do Estado de São Paulo (ICESP)
City
São Paulo
Country
Brazil
Facility Name
Alberta Health Services Cross Cancer Institute
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
McGill University Faculty of Medicine - Royal Victoria Hospital
City
Montréal
ZIP/Postal Code
H3G 1Y6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
University Hospital Olomouc, Department of Oncology
City
Olomouc
ZIP/Postal Code
77020
Country
Czechia
Facility Name
Thomayerova Nemocnice
City
Praha
ZIP/Postal Code
14059
Country
Czechia
Facility Name
CHRU de Tours - Hôpital Trousseau
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Prive Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Antoine-Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Bordeaux - Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Strasbourg Oncologie Liberale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Studiengesellschaft BSF
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Martin Luther Universitat Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Facharztzentrum Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Marienkrankenhaus Hamburg
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Slk-Kliniken
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Klinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Agios Savvas Anticancer Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
General Hospital of Athens - Laiko
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
National and Kapodistrian University of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Ioannina
City
Ioánnina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Theagenion Hospital
City
Thessaloníki
ZIP/Postal Code
54007
Country
Greece
Facility Name
Dél-pesti Centrumkórház - Szent László Kórház telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
City
Budapest
ZIP/Postal Code
H-1089
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
Beer Sheva
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
AOU Ospedali Riuniti di Ancona
City
Torrette
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Champalimaud Cancer Center
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano
City
Senhora da Hora
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Evimed LLC
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Limited Liability Company- Clinica Druzhkovyh
City
Kazan
ZIP/Postal Code
420126
Country
Russian Federation
Facility Name
Kursk Regional Clinical Oncology Dispensary
City
Kursk
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
Main Military Clinical Hospital named after N.N. Burdenko
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Volga District Medical Centre
City
Novgorod
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche
City
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau Barcelona
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Institut Catala d'Oncologia - L'Hospitalet
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Foundation Trust
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
IPD Sharing Time Frame
Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
IPD Sharing Access Criteria
Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
Learn more about this trial
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
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