770
Participants
Start Date
February 11, 2020
Primary Completion Date
July 23, 2022
Study Completion Date
February 18, 2025
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.
Medical University of Vienna, Vienna
Dél-pesti Centrumkórház - Szent László Kórház telephely, Budapest
Országos Onkológiai Intézet, Budapest
Bankstown-Lidcombe Hospital, Bankstown
Universitair Ziekenhuis Antwerpen (UZA), Edegem
University Hospital (UZ) Leuven, Leuven
Monash Medical Centre, Clayton
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz
Queen Elizabeth Hospital, Woodville South
CIP Centro Integrado de Pesquisas do Hospital de Base, São José do Rio Preto
University Hospital Mont-Godinne, Yvoir
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame, Charleroi
St John of God Subiaco Hospital, Subiaco
Sir Charles Gairdner Hospital, Nedlands
Fiona Stanley Hospital, Murdoch
Hospital centre Jolimont, Haine-Saint-Paul
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár
Medizinische Universitaet Graz, Graz
University Hospital Gent, Ghent
Onze-Lieve-Vrouwziekenhuis, Aalst
Clinical Research Alliance, Inc, Lake Success
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York
Charité - Universitaetsmedizin Berlin, Berlin
National Cancer Center, Goyang-si
Agios Savvas Anticancer Hospital, Athens
General Hospital of Athens - Laiko, Athens
National and Kapodistrian University of Athens, Athens
Stony Brook University Medical Center, Stony Brook
CHA Bundang Medical Center, Gyeonggi-do
Thomayerova Nemocnice, Prague
University of Rochester, Rochester
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves, Granada
Istituto Europeo di Oncologia, Milan
Facharztzentrum Eppendorf, Hamburg
Maryland Oncology Hematology, Silver Spring
Virginia Cancer Specialists, Fairfax
Marienkrankenhaus Hamburg, Hamburg
Asklepios Klinik Altona, Hamburg
Blue Ridge Cancer Care, Wytheville
Hospital General Universitario Gregorio Marañon, Madrid
Fundacion Jimenez Diaz, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Centro Integral Oncologico Clara Campal, Madrid
Messino Cancer Center, Asheville
Hospital Regional Universitario de Malaga, Málaga
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto, Piacenza
Greenville Hospital System, Greenville
Medizinische Hochschule Hannover, Hanover
Complejo Hospitalario de Navarra, Pamplona
Florida Cancer Specialists - Panhandle, Tallahassee
Mount Sinai Medical Center of Florida, Inc., Miami Beach
Miami Cancer Institute, Miami
Florida Cancer Specialists - East, West Palm Beach
CHU Bordeaux - Hopital Haut-Leveque, Pessac
Florida Cancer Specialists - St. Petersburg, Tampa
Florida Cancer Specialists - Fort Myers, Sarasota
University of Alabama at Birmingham, Birmingham
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma, Verona
CHRU de Tours - Hôpital Trousseau, Chambray-lès-Tours
Sarah Cannon and HCA Research Institute, Nashville
Chattanooga Oncology Hematology Care - Tennessee Oncology, Chattanooga
The West Cancer Center, Memphis
Hospital Universitario Marques de Valdecilla, Santander
Policlinico S. Orsola-Malpighi, Bologna
University of Kentucky Markey Cancer Center, Lexington
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH, Mönchengladbach
Azienda Ospedaliero-Universitaria di Modena, Modena
Pikeville Medical Center, Pikeville
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James), Columbus
Toledo Clinic Cancer Center, Toledo
St. Josef-Hospital, Bochum
University General Hospital of Ioannina, Ioannina
Fort Wayne Medical Oncology and Hematology, Fort Wayne
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola
Inje University Haeundae Paik Hospital, Busan
Henry Ford Health System, Detroit
Cancer and Hematology Centers of Western Michigan, Grand Rapids
Fakultni nemocnice Hradec Kralove, Hradec Králové
Hospital Universitario Miguel Servet, Zaragoza
Siouxland Hematology - Oncology Associates, LLP, Sioux City
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee
Theagenion Hospital, Thessaloniki
Health Partners Institute, Minneapolis
Mayo Clinic - Rochester, Rochester
Azienda Ospedaliero Universitaria Pisana, Pisa
Centre Oscar Lambret, Lille
Frontier Cancer Center, Billings
AOU Ospedali Riuniti di Ancona, Torrette
Krankenhaus Nordwest, Frankfurt
Edward Hospital - Elmhurst, Elmhurst
Rush University Medical Center, Chicago
Illinois CancerCare - Peoria, Peoria
Carle Cancer Center, Urbana
Research Medical Center, Kansas City
Masarykuv onkologicky ustav, Brno
Strasbourg Oncologie Liberale, Strasbourg
Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha
Klinikum Mannheim, Mannheim
Hôpital Edouard Herriot, Lyon
Centre Leon Berard, Lyon
Hopital Prive Jean Mermoz, Lyon
Ochsner Clinic Foundation, New Orleans
Hematology Oncology Clinic, Baton Rouge
Willis-Knighton Cancer Center, Shreveport
Universitaetsklinikum Tuebingen, Tübingen
University of Oklahoma - Health Sciences Center, Oklahoma City
Klinikum Esslingen GmbH, Esslingen am Neckar
Slk-Kliniken, Heilbronn
Hopital Saint Louis, Paris
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
Texas Oncology - Tyler, Tyler
The Center for Cancer and Blood Disorders, Fort Worth
Texas Oncology - Wichita Falls, Wichita Falls
University Hospital Olomouc, Department of Oncology, Olomouc
Baylor College of Medicine, Houston
Houston Methodist Research Institute, Houston
MD Anderson Cancer Center, Houston
Oncology Consultants, Houston
Texas Oncology - Austin, Austin
Rocky Mountain Cancer Center, Denver
UC Health Memorial Hospital, Colorado Springs
Utah Cancer Specialists, Salt Lake City
Mayo Clinic - Scottsdale, Phoenix
Banner Health- MD Anderson Cancer Center, Gilbert
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital, Poitiers
Universitaetsklinikum Ulm, Ulm
Comprehensive Cancer Centers of Nevada, Las Vegas
University of California, Los Angeles (UCLA), Los Angeles
Torrance Memorial Physician Network Cancer Care, Redondo Beach
Presbyterian Intercommunity Hospital (PIH), Whittier
City of Hope National Medical Center, Duarte
University of California- Irvine Health Cancer Cente, Costa Mesa
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare, Orange
University of California - Irvine Medical Center, Orange
Comprehensive Blood And Cancer Center, Bakersfield
Sutter Health Sacramento, Sacramento
Hospital Bruno Born, Lajeado
Compass Oncology - Rose Quarter Cancer Center, Portland
Kaiser Permanente - Northwest, Portland
Oregon Health & Science University (OHSU), Portland
Oncology Associates of Oregon, Eugene
Hospital de Caridade de Ijui, Ijuí
Main Military Clinical Hospital named after N.N. Burdenko, Moscow
Kursk Regional Clinical Oncology Dispensary, Kursk
Limited Liability Company- Clinica Druzhkovyh, Kazan'
Evimed LLC, Chelyabinsk
Volga District Medical Centre, Veliky Novgorod
Rambam Health Care Campus, Haifa
Maine Center for Cancer Medicine, Scarborough
Beth Israel Deaconess, Boston
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh, Salzburg
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos
Centro Regional Integrado de Oncologia (CRIO), Ceará
Instituto de Oncologia do Parana - IOP, Curitiba
Centro de Pesquisas Oncológicas - CEPON, Florianópolis
Clinica Neoplasias Litoral, Itajaí
Centro de Pesquisas Clinicas de Natal - CPCLIN, Natal
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Instituto do Cancer do Estado de São Paulo (ICESP), São Paulo
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov, Saint Petersburg
Instituto Nacional Do Cancer (INCA), Rio de Janeiro
Instituto COI, Rio de Janeiro
Hospital Alemão Oswaldo Cruz, São Paulo
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo), São Paulo
Alberta Health Services Cross Cancer Institute, Edmonton
Queen Elizabeth II Health Sciences Centre, Halifax
McGill University Faculty of Medicine - Royal Victoria Hospital, Montreal
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke
Centre Antoine-Lacassagne, Nice
Studiengesellschaft BSF, Halle
Martin Luther Universitat Halle-Wittenberg, Halle
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika, Budapest
Debreceni Egyetem Klinikai Kozpont, Debrecen
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet, Szolnok
Soroka Medical Center, Beersheba
Hospital de Braga, Braga
Champalimaud Cancer Center, Lisbon
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria, Lisbon
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano, Senhora da Hora
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia
Asan Medical Center, Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul
Korea University Guro Hospital, Seoul
Hospital General Universitario de Elche, Alicante
Hospital Universitario de Badajoz, Badajoz
Hospital Germans Trias i Pujol, Badalona
Hospital Quironsalud Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona
Hospital Vall D Hebron, Barcelona
Hospital Clinic Barcelona, Barcelona
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell, Barcelona
Institut Catala d'Oncologia - L'Hospitalet, Barcelona
Guy's and St. Thomas' NHS Foundation Trust, London
Royal Marsden Foundation Trust, London
Royal Marsden Foundation Trust, London
Imperial College Healthcare NHS Trust, London
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology, Manchester
Nottingham City Hospital, Nottingham
Lead Sponsor
Ipsen
INDUSTRY