Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring GSI, Gilead, Gilead Sciences, GS-6624, Colorectal Cancer, KRAS, Oncology, monoclonal antibody
Eligibility Criteria
Inclusion Criteria:
- Metastatic colorectal carcinoma with KRAS mutation
- 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:
- More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Clearview Cancer Institute
- Banner MD Anderson Cancer Center
- Central Hematology Oncology Medical Group, Inc.
- Comprehensive Blood and Cancer Center
- Providence Saint Joseph Medical Center-Disney Family Cancer Center
- Wilshire Oncology Medical Group, Inc.
- Saint Jude Heritage Healthcare
- University of California San Diego Medical Center
- Pacific Shores Medical Group
- Comprehensive Hematology Oncology Centers, Inc.
- TORI Network (Translational Oncology Research Intl)
- UCLA Community Oncology Practice
- Stanford University Medical Center
- Wilshire Oncology Medical Group, Inc.
- Cancer Care Associates Medical Group
- Pacific Shores Medical Group
- Sharp Health Care
- San Jose Medical Group
- Central Coast Medical Oncology Corp
- Yale University Smilow Cancer Hospital
- Georgetown University
- Florida Cancer Specialists
- MD Anderson Cancer Center
- Florida Cancer Specialists
- Peachtree Hematology Oncology Consultants, PC
- Suburban Hematology Oncology Associates, PC
- Northwestern University
- Indiana University Simon Cancer Center
- Tufts Medical Center
- Dana Farber Cancer Institute
- West Michigan Cancer Center
- Hematology and Oncology Associates at BridgePoint
- Saint Joseph Oncology, Inc.
- Montana Cancer Institute
- Southeast Nebraska Cancer Center
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- New York University Clinical Cancer Center
- Oncology Hematology Care, Inc.
- Signal Point Clinical Research Center, LLC
- Oncology Hematology Care, Inc.
- Kaiser Permanente Northwest Region Oncology Hematology
- South Carolina Oncology Associates
- Tennessee Oncology, PLLC
- University of Texas Southwestern Medical Center at Dallas
- Center for Cancer and Blood Disorders, PC
- Joe Arrington Cancer Research and Treatment Center
- Scott & White Memorial
- The Center for Cancer and Blood Disorders
- Intermountain Healthcare
- Utah Cancer Specialists
- Virginal Cancer Specialists, PC
- Virginia Cancer Institute
- Virginia Cancer Institute
- Seattle Cancer Care Alliance
- University of Wisconsin
- Centre Hospitalier Universitaire Estaing
- Centre Eugène Marquis
- Centre Georges François Leclerc
- Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
- Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
- Centre Antoine Lacassagne
- Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
- Hôpital Trousseau - Service de Gastroenterologie
- Universitätsklinikum Ulm
- Universitätsklinikums Mannheim
- Ludwig-Maximilians-Universität München Klinikum Großhadern
- Universitätsklinikum Rostock
- Klinikum Region Hannover GmbH, Krankenhaus Siloah
- Medizinische Universitätsklinik Bochum
- Universitätsklinikum Essen
- Krankenanstalt Mutterhaus der Borromäerinnen e.V.
- Universitätsklinikum Dresden
- Universitätsklinikum der Friedrich-Schiller-Universität Jena
- Städtisches Klinikum Frankfurt-Höchst
- Katholisches Marienkrankenhaus gGmbH
- University Magdeburg
- Ospedale Unico Versilia
- Azienda Ospedaliera San Gerardo di Monza
- Arcispedale Santa Maria Nuova IRCCS
- Istituto Europeo di Oncologia
- Ospedale Niguarda Cà Granda
- Ospedale Civile SS Annunziata ASL 1
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
- Uniwersyteckie Centrum Kliniczne
- Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
- Centralny Szpital Kliniczny MSWiA
- Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
- State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
- Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
- Kursk Regional Oncologic Dispensary
- Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
- Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
- State Institution "Blokhin Cancer Research Centre RAMS"
- Nizhny Novgorod City Oncology Dispensary
- State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
- N.N.Petrov Research Institute of Oncology
- Centro Oncológico Regional de Galicia
- Hospital Nuestra Señora de Sonsoles
- Hospital Universitario Vall d'Hebron
- Hospital Universitario de Girona Doctor Josep Trueta
- Hospital Universitario Ramón y Cajal
- Hospital Clinico Universitario San Carlos
- Hospital Universitario 12 de Octubre
- Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
- Hospital Universitario La Paz
- Instituto de Investigación Sanitaria
- Hospital Clinico Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
FOLFIRI + SIM 700 mg (Part A)
FOLFIRI + SIM 200 mg (Part B)
FOLFIRI + SIM 700 mg (Part B)
FOLFIRI + Placebo (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.
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.
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.
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.