Spots Global Cancer Trial Database for A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
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Trial Identification
Brief Title: A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
Official Title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE
Study ID: NCT05171075
Study Description
Brief Summary: This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)
Detailed Description: Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Washington DC VAMC, Washington, District of Columbia, United States
University of Miami Health System/Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
NorthShore University Health System, Evanston, Illinois, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Middletown, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center-Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center-West Harrison, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
University of Pennsylvania - Penn Blood Disorders Center, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
University of Texas Mays Cancer Center, San Antonio, Texas, United States
Blacktown Hospital, Blacktown, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Northern Health, Epping, Victoria, Australia
Concord Repatriation General Hospital, Concord, , Australia
Perth Blood Institute, Perth, , Australia
The Alfred Hospital, Prahran, , Australia
LKH - Universitätsklinikum Graz, Graz, , Austria
LK Wiener Neustadt, Neustadt, , Austria
Medical University of Vienna, Vienna, , Austria
Hamilton Health Sciences, Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada
Ottawa Hospital Research Instituite, Ottawa, Ontario, Canada
Ottawa Hospital Research Instituite, Ottawa, Ontario, Canada
Niagara Health System, Saint Catharines, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
University of Calgary, Calgary, , Canada
Sault Area Hospital, Marie, , Canada
Toronto General Hospital, Toronto, , Canada
Beijing Shijitan Hosp., Beijing, , China
Peking University Third Hospital, Beijing, , China
Jilin Province Tumor Hospital, Ch'ang-ch'un, , China
Southern Medical University - Zhujiang Hospital, Guangdong, , China
The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, , China
Huizhou Municipal Central Hospital, Huizhou, , China
Nanjing First Hospital, Nanjing, , China
Union Hospital Tongji Medical College Huazhong University of Science &Technology, Wuhan, , China
Hubei Cancer Hospital, Wuhan, , China
The Second Hospital of Jiaxing, Zhejiang, , China
Masarykuv onkologicky ustav, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Králové, , Czechia
Nemocnice Na Pleši s.r.o., Nová Ves Pod Pleší, , Czechia
Onkologická klinika VFN a 1. LF UK, Prague, , Czechia
Thomayerova nemocnice, Praha, , Czechia
CHU de Brest - Hôpital de la Cavale Blanche, Brest, Cedex, France
CHU de Limoges - Hôpital Dupuytren, Limoges, Cedex, France
CH Le Puy en Velay, Le Puy-en-Velay, Chantemesse, France
Hôpital Louis Mourier, Colombes, Renouiflers, France
CHU de Nancy - Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy, Rue Du Morvan, France
CHU Amiens - Hopital Nord, Amiens, , France
CHU Angers - Hôpital Hôtel Dieu, Angers, , France
CHU Clermont Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand, , France
CHU Dijon - Hôpital Bocage Central, Dijon, , France
CHU de Grenoble - Hôpital Albert Michallon, Grenoble, , France
CHU de Limoges - Hôpital Dupuytren, Limoges, , France
Hopital Timone Adultes, Marseille, , France
Groupe Hospitalier Pitie-Salpetriere, Paris, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud, Pierre-Bénite, , France
CHU de Rouen - Hôpital de Bois Guillaume, Rouen, , France
CHU de Saint-Etienne - Hopital Nord, Saint-Étienne, , France
CHU Strasbourg - Nouvel Hôpital Civil, Strasbourg, , France
Nouvel Hôpital Civil de Strasbourg, Strasbourg, , France
Centre Hospitalier Intercommunal de Toulon, Toulon, , France
CHU de Nancy - Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy, , France
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt, Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, , Germany
Praxis für Gefäßmedizin, Görlitz, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinik der Christian-Albrechts-Universität, Kiel, , Germany
Universitätsklinik Leipzig, Leipzig, , Germany
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger, , Hungary
Bacs-Kiskun County Hospital, Kecskemét, , Hungary
University of Pécs, Pécs, , Hungary
Cork University Hospital, Cork, , Ireland
Bon Secour Hospital, Cork, , Ireland
Beaumont Hospital, Dublin, , Ireland
University Hospital, Limerick, Limerick, , Ireland
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Bologna, , Italy
Presidio Ospedaliero di Castelfranco Veneto, Castelfranco Veneto, , Italy
SS. ma Annunziata, Chieti, , Italy
Ospedale Civile Dell Annunziata, Cosenza, , Italy
Ospedale Degli Infermi, Faenza, , Italy
Azienda Ospedaliero Universitaria San Martino, Genova, , Italy
Presidio Ospedaliero della Misericordia, Grosseto, , Italy
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo, Milano, , Italy
A.O.U. Policlinico di Modena, Modena, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Azienda Ospedale - Università Padova, Padova, , Italy
Ospedale Universitario, Padova, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia, Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS., Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Ospedale Santa Maria di Cà Foncello, Treviso, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine, , Italy
Università dell'Insubria, Varese, , Italy
Ospedale SS. Giovanni e Paolo, Venezia, , Italy
Ospedalemichele e Pietro ferrer, Verduno, , Italy
Ospedale San Bortolo di Vicenza, Vicenza, , Italy
Hallym University Sacred Heart Hospital, Anyang-Si, , Korea, Republic of
SoonChunHyang University Hospital Bucheon, Bucheon, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Yongin Severance Hospital, Yonsei University Health System, Gyeonggi-do, , Korea, Republic of
Myongji Hospital, Jeonju, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju, , Korea, Republic of
Dong-A University Hospital, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Soonchunhyang University Seoul Hospital, Seoul, , Korea, Republic of
Kyung Hee University Hospital at Gangdong, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Daugavpils Regional Hospital, Daugavpils, , Latvia
Liepaja Regional Hospital, Liepāja, , Latvia
Pauls Stradins CUH, Riga, , Latvia
Riga East Clinical University Hospital, Riga, , Latvia
Meander Medisch Centrum, Amersfoort, , Netherlands
Onze Lieve Vrouwe Gasthuis, Locatie Oost, Amsterdam, , Netherlands
Rode Kruis Ziekenhuis, Beverwijk, , Netherlands
Haga Ziekenhuis, Den Haag, , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid, Haarlem, , Netherlands
Tergooiziekenhuizen, Hilversum, Hilversum, , Netherlands
Amsterdam University Medical Center, Holland, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Radboud Universitair Medisch Centrum, Nijmegen, , Netherlands
Ikazia Ziekenhuis, Rotterdam, , Netherlands
Østfold Hospital Kalnes, Fredrikstad, , Norway
Akershus Univeristy Hospital, Lørenskog, , Norway
Oslo University Hospital, Dep of Haematology, Oslo, , Norway
Hospital Universitario Del Vinalopo, Alicante, , Spain
Complejo Hospital Vall D'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Hospital General Universitario de Elche, Elche, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
Hospital Universitario Ciudad de Jaen, Jaén, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, , Spain
Complejo Hospitalario Universitario de Ourense, Ourense, , Spain
Hospital Universitario Central de Asturia, Oviedo, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Corporacio Sanitaria Parc Tauli, Sabadell, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago De Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Länssjukhuset Sundsvall-Härnösand, Sundsvall, , Sweden
Hopital Universitaire Geneve, Geneve, , Switzerland
University of Zürich, Zürich, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Far Eastern Memorial Hospital, New Taipei City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University (NCKU) Hospital, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
University Hospital of Wales, Cardiff, England, United Kingdom
Barts Health NHS Trust, London, England, United Kingdom
Castle Hill Hospital, Department of Oncology & Haematology, Cottingham, ENG, United Kingdom
The Newcastle Upon Tyne Hospitals, Newcastle Upon Tyne, ENG, United Kingdom
Queen Elizabeth University Hospital Campus, Glasgow, SCO, United Kingdom
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