Spots Global Cancer Trial Database for Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
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Trial Identification
Brief Title: Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen
Study ID: NCT01479465
Conditions
Study Description
Brief Summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clearview Cancer Institute, Huntsville, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Central Hematology Oncology Medical Group, Inc., Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Providence Saint Joseph Medical Center-Disney Family Cancer Center, Burbank, California, United States
Wilshire Oncology Medical Group, Inc., Corona, California, United States
Saint Jude Heritage Healthcare, Fullerton, California, United States
University of California San Diego Medical Center, La Jolla, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Comprehensive Hematology Oncology Centers, Inc., Los Angeles, California, United States
TORI Network (Translational Oncology Research Intl), Los Angeles, California, United States
UCLA Community Oncology Practice, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
Wilshire Oncology Medical Group, Inc., Pomona, California, United States
Cancer Care Associates Medical Group, Redondo Beach, California, United States
Pacific Shores Medical Group, Redondo Beach, California, United States
Sharp Health Care, San Diego, California, United States
San Jose Medical Group, San Jose, California, United States
Central Coast Medical Oncology Corp, Santa Maria, California, United States
Yale University Smilow Cancer Hospital, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
Florida Cancer Specialists, Gainesville, Florida, United States
MD Anderson Cancer Center, Orlando, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Peachtree Hematology Oncology Consultants, PC, Atlanta, Georgia, United States
Suburban Hematology Oncology Associates, PC, Lawrenceville, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Hematology and Oncology Associates at BridgePoint, Tupelo, Mississippi, United States
Saint Joseph Oncology, Inc., Saint Joseph, Missouri, United States
Montana Cancer Institute, Missoula, Montana, United States
Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New York University Clinical Cancer Center, New York, New York, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Oncology Hematology Care, Inc., Wilmington, Ohio, United States
Kaiser Permanente Northwest Region Oncology Hematology, Portland, Oregon, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
Center for Cancer and Blood Disorders, PC, Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Scott & White Memorial, Temple, Texas, United States
The Center for Cancer and Blood Disorders, Weatherford, Texas, United States
Intermountain Healthcare, Saint George, Utah, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virginal Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Cancer Institute, Midlothian, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Centre Hospitalier Universitaire Estaing, Clermont Ferrand, Auvergne, France
Centre Eugène Marquis, Rennes Cedex, Bretagne, France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique, Lille Cedex, , France
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi, Montpellier Cedex 5, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer, Rennes Cedex, , France
Hôpital Trousseau - Service de Gastroenterologie, Tours, , France
Universitätsklinikum Ulm, Ulm, Baden-Wuerttemberg, Germany
Universitätsklinikums Mannheim, Mannheim, Baden-Wuerttenberg, Germany
Ludwig-Maximilians-Universität München Klinikum Großhadern, München, Bayern, Germany
Universitätsklinikum Rostock, Rostock, Mecklenburg-Vorpommern, Germany
Klinikum Region Hannover GmbH, Krankenhaus Siloah, Hannover, Niedersachsen, Germany
Medizinische Universitätsklinik Bochum, Bochum, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Krankenanstalt Mutterhaus der Borromäerinnen e.V., Trier, Rheinland-Pfalz, Germany
Universitätsklinikum Dresden, Dresden, Sachsen, Germany
Universitätsklinikum der Friedrich-Schiller-Universität Jena, Jena, Thuringen, Germany
Städtisches Klinikum Frankfurt-Höchst, Frankfurt, , Germany
Katholisches Marienkrankenhaus gGmbH, Hamburg, , Germany
University Magdeburg, Magdeburg, , Germany
Ospedale Unico Versilia, Lido di Camaiore, Lucca, Italy
Azienda Ospedaliera San Gerardo di Monza, Monza, Monza E Brianza, Italy
Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, Reggio Nella Emilia, Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale Niguarda Cà Granda, Milano, , Italy
Ospedale Civile SS Annunziata ASL 1, Sassari, , Italy
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o., Kraków, Malopolskie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o., Olsztyn, Warminsko-Mazurskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Centralny Szpital Kliniczny MSWiA, Warszawa, , Poland
Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie, Warszawa, , Poland
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk, , Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan, , Russian Federation
Kursk Regional Oncologic Dispensary, Kursk, , Russian Federation
Cancer Research Center n.a. Blokhin, Chemotherapy Dept., Moscow, , Russian Federation
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD", Moscow, , Russian Federation
State Institution "Blokhin Cancer Research Centre RAMS", Moscow, , Russian Federation
Nizhny Novgorod City Oncology Dispensary, Nizhny Novgorod, , Russian Federation
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary", Omsk, , Russian Federation
N.N.Petrov Research Institute of Oncology, Saint Petersburg, , Russian Federation
Centro Oncológico Regional de Galicia, A Coruña, La Coruna, Spain
Hospital Nuestra Señora de Sonsoles, Avila, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de Girona Doctor Josep Trueta, Gerona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico Universitario San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Instituto de Investigación Sanitaria, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Zung Thai, MD
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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