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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
Sponsor: Ipsen
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
770
Start Date
2020-02-11
Completion Date
2025-02-18
Last Updated
2026-04-20
Healthy Volunteers
No
Interventions
Irinotecan Liposomal Injection
Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).
Oxaliplatin
Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
5Fluorouracil
Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.
Leucovorin
Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
Nab-paclitaxel
Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
Gemcitabine
Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.
Locations (200)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health- MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
University of California- Irvine Health Cancer Cente
Costa Mesa, California, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Torrance Memorial Physician Network Cancer Care
Redondo Beach, California, United States
Sutter Health Sacramento
Sacramento, California, United States
Presbyterian Intercommunity Hospital (PIH)
Whittier, California, United States
UC Health Memorial Hospital
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Miami Cancer Institute
Miami, Florida, United States
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, United States
Florida Cancer Specialists - Fort Myers
Sarasota, Florida, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
Florida Cancer Specialists - St. Petersburg
Tampa, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Edward Hospital - Elmhurst
Elmhurst, Illinois, United States
Illinois CancerCare - Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Siouxland Hematology - Oncology Associates, LLP
Sioux City, Iowa, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Health Partners Institute
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Frontier Cancer Center
Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Clinical Research Alliance, Inc
Lake Success, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, United States
Kaiser Permanente - Northwest
Portland, Oregon, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Chattanooga Oncology Hematology Care - Tennessee Oncology
Chattanooga, Tennessee, United States
The West Cancer Center
Memphis, Tennessee, United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology - Wichita Falls
Wichita Falls, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Wytheville, Virginia, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital
Bankstown, Australia
Monash Medical Centre
Clayton, Australia
Fiona Stanley Hospital
Murdoch, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
St John of God Subiaco Hospital
Subiaco, Australia
Queen Elizabeth Hospital
Woodville South, Australia
Medizinische Universitaet Graz
Graz, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh
Salzburg, Austria
Medical University of Vienna
Vienna, Austria
Onze-Lieve-Vrouwziekenhuis
Aalst, Belgium
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
Charleroi, Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
University Hospital Gent
Ghent, Belgium
Hospital centre Jolimont
Haine-Saint-Paul, Belgium
University Hospital (UZ) Leuven
Leuven, Belgium
University Hospital Mont-Godinne
Yvoir, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, Brazil
Centro Regional Integrado de Oncologia (CRIO)
Ceará, Brazil
Instituto de Oncologia do Parana - IOP
Curitiba, Brazil
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, Brazil
Hospital de Caridade de Ijui
Ijuí, Brazil
Clinica Neoplasias Litoral
Itajaí, Brazil
Hospital Bruno Born
Lajeado, Brazil
Centro de Pesquisas Clinicas de Natal - CPCLIN
Natal, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Instituto Nacional Do Cancer (INCA)
Rio de Janeiro, Brazil
Instituto COI
Rio de Janeiro, Brazil