266
Participants
Start Date
December 31, 2011
Primary Completion Date
October 31, 2014
Study Completion Date
February 28, 2015
Simtuzumab
SIM administered via intravenous infusion over 30 minutes
Placebo to match SIM
Placebo to match SIM administered via intravenous infusion over 30 minutes
Leucovorin
l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours
Irinotecan
Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes
Fluorouracil
Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours
New York University Clinical Cancer Center, New York
Centro Oncológico Regional de Galicia, A Coruña
Hospital Universitario de Girona Doctor Josep Trueta, Girona
Universitätsklinikum Rostock, Rostock
Azienda Ospedaliera San Gerardo di Monza, Monza
Istituto Europeo di Oncologia, Milan
Ospedale Niguarda Cà Granda, Milan
Virginal Cancer Specialists, PC, Fairfax
Katholisches Marienkrankenhaus gGmbH, Hamburg
Hospital Universitario Ramón y Cajal, Madrid
Hospital Clinico Universitario San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid
Klinikum Region Hannover GmbH, Krankenhaus Siloah, Hanover
Centre Eugène Marquis, Rennes
Clearview Cancer Institute, Huntsville
Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia
Medizinische Universitätsklinik Bochum, Bochum
Universitätsklinikum Essen, Essen
Hospital Clinico Universitario de Valencia, Valencia
Krankenanstalt Mutterhaus der Borromäerinnen e.V., Trier
Ospedale Unico Versilia, Lido di Camaiore
Montana Cancer Institute, Missoula
Centre Hospitalier Universitaire Estaing, Clermont-Ferrand
Universitätsklinikums Mannheim, Mannheim
Scott & White Memorial, Temple
Ludwig-Maximilians-Universität München Klinikum Großhadern, München
Universitätsklinikum Ulm, Ulm
Banner MD Anderson Cancer Center, Gilbert
Central Hematology Oncology Medical Group, Inc., Alhambra
Comprehensive Blood and Cancer Center, Bakersfield
Providence Saint Joseph Medical Center-Disney Family Cancer Center, Burbank
Wilshire Oncology Medical Group, Inc., Corona
Saint Jude Heritage Healthcare, Fullerton
University of California San Diego Medical Center, La Jolla
Pacific Shores Medical Group, Long Beach
Comprehensive Hematology Oncology Centers, Inc., Los Angeles
TORI Network (Translational Oncology Research Intl), Los Angeles
UCLA Community Oncology Practice, Los Angeles
Stanford University Medical Center, Palo Alto
Wilshire Oncology Medical Group, Inc., Pomona
Cancer Care Associates Medical Group, Redondo Beach
Pacific Shores Medical Group, Redondo Beach
Sharp Health Care, San Diego
San Jose Medical Group, San Jose
Central Coast Medical Oncology Corp, Santa Maria
Georgetown University, Washington D.C.
Florida Cancer Specialists, Gainesville
MD Anderson Cancer Center, Orlando
Florida Cancer Specialists, St. Petersburg
Peachtree Hematology Oncology Consultants, PC, Atlanta
Suburban Hematology Oncology Associates, PC, Lawrenceville
Northwestern University, Chicago
Indiana University Simon Cancer Center, Indianapolis
Dana Farber Cancer Institute, Boston
West Michigan Cancer Center, Kalamazoo
Hematology and Oncology Associates at BridgePoint, Tupelo
Saint Joseph Oncology, Inc., Saint Joseph
Southeast Nebraska Cancer Center, Lincoln
Comprehensive Cancer Centers of Nevada, Henderson
Comprehensive Cancer Centers of Nevada, Las Vegas
Oncology Hematology Care, Inc., Cincinnati
Signal Point Clinical Research Center, LLC, Middletown
Oncology Hematology Care, Inc., Wilmington
Kaiser Permanente Northwest Region Oncology Hematology, Portland
South Carolina Oncology Associates, Columbia
Tennessee Oncology, PLLC, Nashville
University of Texas Southwestern Medical Center at Dallas, Dallas
Center for Cancer and Blood Disorders, PC, Fort Worth
Joe Arrington Cancer Research and Treatment Center, Lubbock
The Center for Cancer and Blood Disorders, Weatherford
Utah Cancer Specialists, Salt Lake City
Intermountain Healthcare, St. George
Virginia Cancer Institute, Midlothian
Virginia Cancer Institute, Richmond
Seattle Cancer Care Alliance, Seattle
University of Wisconsin, Madison
Centre Georges François Leclerc, Dijon
Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique, Lille
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi, Montpellier
Centre Antoine Lacassagne, Nice
Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer, Rennes
Hôpital Trousseau - Service de Gastroenterologie, Tours
Städtisches Klinikum Frankfurt-Höchst, Frankfurt
University Magdeburg, Magdeburg
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz
Centralny Szpital Kliniczny MSWiA, Warsaw
Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie, Warsaw
"State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan'
Kursk Regional Oncologic Dispensary, Kursk
Cancer Research Center n.a. Blokhin, Chemotherapy Dept., Moscow
"Non-State Institution of healthcare Central Clinical Hospital #1 OAO RZD", Moscow
"State Institution Blokhin Cancer Research Centre RAMS", Moscow
Nizhny Novgorod City Oncology Dispensary, Nizhny Novgorod
"State Healthcare Institution of Omsk Region Clinical Oncologic Dispensary", Omsk
N.N.Petrov Research Institute of Oncology, Saint Petersburg
Hospital Universitario La Paz, Madrid
Instituto de Investigación Sanitaria, Madrid
Yale University Smilow Cancer Hospital, New Haven
Tufts Medical Center, Boston
Universitätsklinikum Dresden, Dresden
Universitätsklinikum der Friedrich-Schiller-Universität Jena, Jena
Ospedale Civile SS Annunziata ASL 1, Sassari
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o., Krakow
Uniwersyteckie Centrum Kliniczne, Gdansk
"Olsztynski Osrodek Onkologiczny Kopernik sp. z o. o.", Olsztyn
Hospital Nuestra Señora de Sonsoles, Ávila
Hospital Universitario Vall d'Hebron, Barcelona
Lead Sponsor
Gilead Sciences
INDUSTRY