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Spots Global Cancer Trial Database for A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

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Trial Identification

Brief Title: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

Official Title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

Study ID: NCT05171049

Interventions

Abelacimab
Apixaban

Study Description

Brief Summary: This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

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. The two most common treatments today are low molecular weight heparin (LMWH) and direct anticoagulants (DOACs), in which each has limitations. DOACs are administered orally and are seen as a more convenient alternative though associated with bleeding risk; further, some cancer patients have difficulty swallowing or develop vomiting which leads to unpredictable pharmacodynamic effects with oral therapy. The ANT-007 study will compare treatment with abelacimab monthly administration to apixaban twice daily administration over a 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

VA Connecticut Healthcare System, West Haven, Connecticut, United States

Washington DC VAMC, Washington, District of Columbia, United States

University of Miami Health, Miami, Florida, United States

NorthShore University Health System, Evanston, Illinois, United States

University of Kentucky, Markey Cancer Center, Lexington, Kentucky, 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

Washington University, 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

Lipson Cancer Institute, Rochester, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

Cleveland Clinic Foundation, Cleveland, Ohio, 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

MD Anderson Cancer Center, Houston, Texas, United States

University of Texas Mays Cancer Center, San Antonio, Texas, United States

Sentara Pulmonary, Critical Care, and Sleep Specialists, Norfolk, Virginia, United States

Gundersen Health System, La Crosse, Wisconsin, United States

Blood Center of Wisconsin, Milwaukee, Wisconsin, United States

Blacktown Hospital, Blacktown, New South Wales, Australia

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Westmead Hospital, Westmead, New South Wales, Australia

Box Hill Hospital, Box Hill, Victoria, Australia

Monash Medical Centre Clayton, Clayton, Victoria, Australia

Northern Health, Epping, Victoria, 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

University of Calgary, Calgary, Alberta, Canada

University of Alberta Hospital, Edmonton, Alberta, Canada

Hamilton Health Sciences, Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada

Ottawa Hospital, Ottawa, Ontario, Canada

Niagara Health System, Saint Catharines, Ontario, Canada

Sault Area Hospital, Sault-Sainte-Marie, Ontario, Canada

Toronto General Hospital, Toronto, Ontario, Canada

Jewish General Hospital, Montréal, Quebec, Canada

McGill University Health Centre, Montréal, Quebec, Canada

Queen Elizabeth II Health Sciences Centre, Nova Scotia, , Canada

McGill University Health Centre, Québec, , 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

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China

Union Hospital Tongji Medical College Huazhong University of Science &Technology, Wuhan, , China

Tongji Hospital, Tongji Medical College, Wuhan, , China

1st Affiliate Hospital of Xi'an Jiao, Xi'an, , China

Masarykuv onkologicky ustav, Brno, , Czechia

University Hospital Hradec Kralove, Hradec Kralove, , 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 Amiens - Hopital Nord, Amiens, , France

CHU Angers - Hôpital Hôtel Dieu, Angers, , France

CHU de Brest - Hôpital de la Cavale Blanche, Brest, , France

CHU Clermont Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand, , France

Hôpital Louis Mourier, Colombes, , France

CHU Dijon - Hôpital Bocage Central, Dijon, , France

CHU de Grenoble - Hôpital Albert Michallon, Grenoble, , France

CH Le Puy en Velay, Le Puy-en-Velay, , France

CHU de Limoges - Hôpital Dupuytren, Limoges, , France

Hopital Timone Adultes, Marseille, , France

Centre hospitalier des pays de Morlaix, Morlaix, , France

Hôpital Européen Georges Pompidou, Paris, , France

Groupe Hospitalier Pitie-Salpetriere, 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 Toulouse - Hôpital Rangueil, Toulouse, , France

CHU de Nancy - Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy, , 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

Universitaetsklinikum Magdeburg A.oe.R, Magdeburg, , Germany

Klinikum der Universitaet Muenchen, Muenchen, , 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

Bon Secour Hospital, Cork, , Ireland

Cork University Hospital, Cork, , Ireland

Beaumont Hospital, Dublin, , Ireland

Msdyrt Midericordiae University 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

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

National Cancer Center Hospital, Tsukiji, Tokyo, Japan

Chibaken Saiseikai Narashino Hospital, Chiba, , Japan

Tokai University Hospital, Isehara, , Japan

Yokohama Minami Kyosai Hospital, Kanagawa, , Japan

Kobe University Hospital, Kobe, , Japan

Kumamoto University Hospital, Kumamoto, , Japan

Kyoto University Hospital, Kyoto, , Japan

Mie University Hospital, Mie, , Japan

Tokyo Saiseikai Central Hospital, Minato-Ku, , Japan

Tohoku University Graduate School of Medicine, Miyagi, , Japan

Okayama Medical Center, Okayama, , Japan

Osaka International Cancer Institute, Osaka, , Japan

International University of Health and Welfare MITA Hospital, Tokyo, , Japan

Juntendo University Hospital, Tokyo, , Japan

Kyorin University Hospital, Tokyo, , Japan

Myongji Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Yongin Severance Hospital, Yonsei University Health System, Yongin-si, Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital, Anyang, , Korea, Republic of

SoonChunHyang University Hospital Bucheon, Bucheon, , Korea, Republic of

Daegu Catholic University Medical Center, Daegu, , Korea, Republic of

Kyung Hee University Hospital at Gangdong, Gangdong, , Korea, Republic of

Jeonbuk National University Hospital, Jeonju, , Korea, Republic of

Dong-A University Hospital, Seogu, , Korea, Republic of

Soonchunhyang University Seoul Hospital, Seoul, , Korea, Republic of

Ewha Womans University Mokdong Hospital, Yangcheon, , Korea, Republic of

Soonchunhyang University Seoul Hospital, Yongsan, , Korea, Republic of

Daugavpils Regional Hospital, Daugavpils, , Latvia

Liepaja Regional Hospital, Liepāja, , Latvia

Pauls Stradins Clinical University Hospital, Riga, , Latvia

Riga East Clinical University hospital, Riga, , Latvia

Meander Medisch Centrum, Amersfoort, , Netherlands

Meander Medisch Centrum, Amersfoort, , Netherlands

Onze Lieve Vrouwe Gasthuis, Locatie Oost, Amsterdam, , 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

Tergooiziekenhuizen, Hilversum, Hilversum, , Netherlands

Amsterdam University Medical Center, Holland, , Netherlands

Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid, Hoofddorp, , 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

Complejo Hospital Vall D'Heborn, Barcelona, , Spain

Hospital Clinic de Barcelona, Barcelona, , Spain

Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain

Hospital Universitario Del Vinalopo, Elche, , 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 Clinico San Carlos, Madrid, , Spain

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, , Spain

Complejo Hospitalario Universitario de Orense, Ourense, , 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

Inselspital - Universitaetsspital Bern, Bern, , Switzerland

Hopital Universitaire Geneve, Geneve, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , 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 Hospital, Tainan, , Taiwan

National Taiwan University Hospital, Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan

Tri-Service General Hospital, Taipei, , Taiwan

University Hospital of Wales, Cardiff, England, United Kingdom

University Hospitals of North Midlands, Stafford, England, United Kingdom

University Hospitals of North Midlands, Stoke-on-Trent, England, United Kingdom

Castle Hill Hospital, Department of Oncology & Haematology, Cottingham, ENG, United Kingdom

Barts Health NHS Trust, London, ENG, United Kingdom

The Newcastle Upon Tyne Hospitals, Newcastle upon Tyne, ENG, United Kingdom

Queen Elizabeth University Hospital Campus, Glasgow, SCO, United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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