Spots Global Cancer Trial Database for A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
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Trial Identification
Brief Title: A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Official Title: Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
Study ID: NCT01767857
Conditions
Study Description
Brief Summary: The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.
Detailed Description: In the setting of refractory, metastatic disease a complete resolution of tumor burden is not a reasonable expectation. Instead, the primary goal of anti-tumor therapy at this stage is to eliminate or reduce the symptomatic effects of the tumor, while trying to prolong survival for as long as possible. Due to treatment related morbidity however, few treatment modalities are ideal for this objective. Even with the most recent targeted agents (such as multi-kinase inhibitors), drug related toxicities frequently lead to relatively short treatment durations. With discontinuation of therapy, disease progression is uncontrolled and prognosis is poor. New agents that control disease progression-while improving tumor-related symptoms, rather than causing significant therapy related morbidity-are vitally needed to treat patients with advanced cancer, including those with colorectal cancer. An approach has been taken to develop such an agent using a monoclonal antibody to block the chronic inflammation involved in both malignant disease progression and constitutional symptoms. Xilonix™ is expected to inhibit tumor growth and metastasis by interrupting crucial signals that drive angiogenesis and invasiveness. The antibody therapy may also block tumor microenvironment infiltration by leukocytes (such as myeloid suppressor cells) that suppress antitumor immunity, enabling better host immune control of the disease. In addition to local effects on the tumor, Xilonix™ is expected to work systemically to correct the metabolic dysregulation, fatigue and anxiety mediated by chronic inflammatory signaling to the central nervous system.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, Bruno Cancer Center, Birmingham, Alabama, United States
Southern Cancer Center, PC, Mobile, Alabama, United States
Northwest Alabama Cancer Center, PC, Muscle Shoals, Alabama, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
California Cancer Associates for Research and Excellence, Inc. (cCARE), Fresno, California, United States
St. Jude Medical Center, Fullerton, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
USC Norris Comprehensive Cancer Center and LAC USC Medical Center, Los Angeles, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
American Institute of Research, Whittier, California, United States
Advanced Medical Specialists, Miami, Florida, United States
Lewis Hall Singletary Oncology Center, Thomasville, Georgia, United States
Swedish Covenant Hospital via Clintell, Inc., Chicago, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Hines VA Hospital, Hines, Illinois, United States
Oncology Specialists, SC, Park Ridge, Illinois, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
Hutchinson Clinic, P.A., Hutchinson, Kansas, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC., Bethesda, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Park Nicollet, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
North Shore Hematology Oncology Associates, PC, East Setauket, New York, United States
Northern Westchester Hospital, Mount Kisco, New York, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook Cancer Center, Stony Brook, New York, United States
East Carolina Health - Beaufort, Inc. DBA Marion L. Shepard Cancer Center, Washington, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
St. Charles Health System, Inc., Bend, Oregon, United States
Good Samaritan Hospital Corvallis - SHOC, Corvallis, Oregon, United States
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Bon Secours Saint Francis Cancer Center, Greenville, South Carolina, United States
Texas Oncology, Bedford, Texas, United States
Coastal Bend Cancer Center, Corpus Christi, Texas, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Dallas, Dallas, Texas, United States
Texas Oncology - Grapevine, Grapevine, Texas, United States
Millennium Oncology, Houston, Texas, United States
Methodist Richardson Cancer Center, Richardson, Texas, United States
Brooke Army Medical Center, San Antonio, Texas, United States
Scott & White Healthcare, Temple, Texas, United States
Texas Oncology - Longview and Tyler, Tyler, Texas, United States
University of TX Health Science Center at Tyler, Tyler, Texas, United States
Virginia Oncology Associates, Multiple Locations, Virginia, United States
Providence Regional Medical Center Everett, PRCP - Clinical Research, Everett, Washington, United States
SCCA - Evergreen Health, Kirkland, Washington, United States
University of Washington, Multiple Locations, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
SCCA - Group Health, Seattle, Washington, United States
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Western Health - Sunshine Hospital, Saint Albans, Victoria, Australia
Hospital Barmherzige Schwestern Linz, Linz, , Austria
Krankenhaus der Barmherzigen Schwestern Linz, Linz, , Austria
LKH Salzburg 3rd Medical Department with Hematology, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, IV. Internal Department, Wels, , Austria
Grand Hôpital de Charleroi, Grand Rue 3, Charleroi, Hainaut, Belgium
CHU Dinant Godinne UCL Namur, Yvoir, Namur, Belgium
Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Antwerp University Hospital, Edegem, , Belgium
Domaine Universitaire du Sart Tilman, Liège, , Belgium
Masarykův onkologický ústav, Brno, , Czechia
Všeobecné fakultní nemocnice v Praze, Onkologická klinika, Praha, , Czechia
Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha, Praha, , Czechia
Fakultní nemocnice v Motole, Komplexní onkologické centrum, Praha, , Czechia
Semmelweis University 1st Dept. Of Internal Medicine, Oncology Division, Budapest, , Hungary
"B" Dept. Of Internal Medicine, National Institute of Oncology, Budapest, , Hungary
Uzsoki Hospital, Dept. of Oncoradiology, Budapest, , Hungary
Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital, Kaposvár, , Hungary
Dept. Of Oncology, Tolna County Balassa Janos Hospital, Szekszárd, , Hungary
Rambam Health Care Campus, Haifa, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
FONDAZIONE POLIAMBULANZA â€" ISTITUTO OSPEDALIERO, Brescia, , Italy
A.O. Universitaria Arcispedale S.Anna Di Ferrara, Cona, , Italy
Azienda Ospedaliera University Pisana Uo Oncol Medica 2, Pisa, , Italy
U.O. Oncologia Medica, Pontedera, , Italy
San Giovanni Calibita" Fatebenefratelli Hospital, Rome, , Italy
Academic Medical Centre Amsterdam, Amsterdam, , Netherlands
Amphia Hospital, Breda, , Netherlands
University Medical Center Utrecht Heidelberglaan, Utrecht, , Netherlands
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Odzial Onkologii Klinicznej, Białystok, , Poland
Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka, Bydgoszcz, , Poland
Szpital Wojewodzki w Gdyni Sp. Z o.o., Szpital Morski im PCK, Gdynia, , Poland
Przychodnia Lekarska "Komed", Konin, , Poland
NZOZ Vesalius, Kraków, , Poland
Samodzielny Publiczny ZOZ MSZ z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej, Warszawa, , Poland
NZOZ Magodent sp z.o.o., Warszawa, , Poland
Instituto Oncológico Dr. Rosell., Barcelona, , Spain
Hospital Vall Dhebron Edificio Principal Planta Baja, Barcelona, , Spain
Institut Català d'Oncologia, Hospital Duran i Reynals, Barcelona, , Spain
Institut Català d'Oncologia, Barcelona, , Spain
Hospital ClÃ-nica Benidorm, Benidorm, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital 12 De Octubre, Madrid, , Spain
CIOCC, Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Son Llà tzer, Palma, , Spain
Hospital Universitario La Fe, Consultas Externas Oncologia, Valencia, , Spain
Istituto Oncologico della Svizzera Italiania, Bellinzona, , Switzerland
Kantonsspital GraubÃnden, Chur, , Switzerland
Christie Hospital, Manchester, Greater Manchester, United Kingdom
The Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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