Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

February 28, 2015

Conditions
Colorectal Cancer
Interventions
BIOLOGICAL

Simtuzumab

SIM administered via intravenous infusion over 30 minutes

DRUG

Placebo to match SIM

Placebo to match SIM administered via intravenous infusion over 30 minutes

DRUG

Leucovorin

l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours

DRUG

Irinotecan

Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes

DRUG

Fluorouracil

Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Trial Locations (109)

10016

New York University Clinical Cancer Center, New York

15009

Centro Oncológico Regional de Galicia, A Coruña

17007

Hospital Universitario de Girona Doctor Josep Trueta, Girona

18055

Universitätsklinikum Rostock, Rostock

20052

Azienda Ospedaliera San Gerardo di Monza, Monza

20141

Istituto Europeo di Oncologia, Milan

20162

Ospedale Niguarda Cà Granda, Milan

22033

Virginal Cancer Specialists, PC, Fairfax

22045

Katholisches Marienkrankenhaus gGmbH, Hamburg

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico Universitario San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid

30449

Klinikum Region Hannover GmbH, Krankenhaus Siloah, Hanover

35042

Centre Eugène Marquis, Rennes

35801

Clearview Cancer Institute, Huntsville

42100

Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia

44892

Medizinische Universitätsklinik Bochum, Bochum

45122

Universitätsklinikum Essen, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

54290

Krankenanstalt Mutterhaus der Borromäerinnen e.V., Trier

55043

Ospedale Unico Versilia, Lido di Camaiore

59802

Montana Cancer Institute, Missoula

63003

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

68167

Universitätsklinikums Mannheim, Mannheim

76508

Scott & White Memorial, Temple

81377

Ludwig-Maximilians-Universität München Klinikum Großhadern, München

89081

Universitätsklinikum Ulm, Ulm

Unknown

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

06520

Yale University Smilow Cancer Hospital, New Haven

02111

Tufts Medical Center, Boston

01307

Universitätsklinikum Dresden, Dresden

07747

Universitätsklinikum der Friedrich-Schiller-Universität Jena, Jena

07100

Ospedale Civile SS Annunziata ASL 1, Sassari

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o., Krakow

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

10-513

"Olsztynski Osrodek Onkologiczny Kopernik sp. z o. o.", Olsztyn

05004

Hospital Nuestra Señora de Sonsoles, Ávila

08035

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY