Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
NCT ID: NCT01479465
Last Updated: 2019-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
266 participants
INTERVENTIONAL
2011-12-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FOLFIRI + SIM 700 mg (Part A)
Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Simtuzumab
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
FOLFIRI + SIM 200 mg (Part B)
Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Simtuzumab
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
FOLFIRI + SIM 700 mg (Part B)
Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Simtuzumab
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
FOLFIRI + Placebo (Part B)
Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received first line therapy and discontinued part or all of first line therapy
* Estimated life expectancy \> 3 months
* Stage IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* Adequate hepatic and hematologic function
* No major operations within 4 weeks prior to treatment start
Exclusion Criteria
* Experimental medical treatment within 30 days prior to study entry
* Known or suspected cerebral metastases
* History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment
* Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
* Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia
* Uncontrolled hypertension (seated systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg) at screening
* Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis
* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
* Prior irinotecan therapy for metastatic disease is not permitted
* Systemic fungal, bacterial, viral, or other infection
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Zung Thai, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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 D.C., District of Columbia, United States
Florida Cancer Specialists
Gainesville, Florida, United States
MD Anderson Cancer Center
Orlando, Florida, United States
Florida Cancer Specialists
St. 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
Utah Cancer Specialists
Salt Lake City, Utah, United States
Intermountain Healthcare
St. George, 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, Brittany Region, France
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
Lille, , France
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
Rennes, , France
Hôpital Trousseau - Service de Gastroenterologie
Tours, , France
Universitätsklinikums Mannheim
Mannheim, Baden-Wuerttenberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Ludwig-Maximilians-Universität München Klinikum Großhadern
München, Bavaria, Germany
Klinikum Region Hannover GmbH, Krankenhaus Siloah
Hanover, Lower Saxony, Germany
Universitätsklinikum Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Medizinische Universitätsklinik Bochum
Bochum, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Krankenanstalt Mutterhaus der Borromäerinnen e.V.
Trier, Rhineland-Palatinate, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
Universitätsklinikum der Friedrich-Schiller-Universität Jena
Jena, Thuringia, 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
Milan, , Italy
Ospedale Niguarda Cà Granda
Milan, , Italy
Ospedale Civile SS Annunziata ASL 1
Sassari, , Italy
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
Krakow, Lesser Poland Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
Olsztyn, Warmian-Masurian Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, , Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, , Poland
Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
Warsaw, , Poland
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, , Russia
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', , Russia
Kursk Regional Oncologic Dispensary
Kursk, , Russia
Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
Moscow, , Russia
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
Moscow, , Russia
State Institution "Blokhin Cancer Research Centre RAMS"
Moscow, , Russia
Nizhny Novgorod City Oncology Dispensary
Nizhny Novgorod, , Russia
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
Omsk, , Russia
N.N.Petrov Research Institute of Oncology
Saint Petersburg, , Russia
Centro Oncológico Regional de Galicia
A Coruña, La Coruna, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Girona Doctor Josep Trueta
Girona, , 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
Countries
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References
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Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28.
Other Identifiers
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2011-003754-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-295-0203
Identifier Type: -
Identifier Source: org_study_id
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