A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE (ASTER)

January 18, 2024 updated by: Anthos Therapeutics, Inc.

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1655

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nancy Widener
Phone Number: 239-284-3741
Email: Nancy.w@anthostherapeutics.com

Study Contact Backup

Name: Deb Freedholm
Phone Number: 609-439-8246
Email: Deb.f@anthostherapeutics.com

Study Locations

Australia
- - Perth, Australia, 6005
    - Recruiting
    - Perth Blood Institute
    - Contact:
      
      Nancy Widener
  - Prahran, Australia, 3181
    - Recruiting
    - The Alfred Hospital
    - Contact:
      
      Nancy Widener
- New South Wales
  - Blacktown, New South Wales, Australia, 2148
    - Recruiting
    - Blacktown Hospital
    - Contact:
      
      Nancy Widener
  - Concord, New South Wales, Australia, 2139
    - Recruiting
    - Concord Repatriation General Hospital
    - Contact:
      
      Nancy Widener
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Westmead Hospital
    - Contact:
      
      Nancy Widener
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Recruiting
    - Box Hill Hospital
    - Contact:
      
      Nancy Widener
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Medical Centre Clayton
    - Contact:
      
      Nancy Widener
  - Epping, Victoria, Australia, 3076
    - Recruiting
    - Northern Health
    - Contact:
      
      Nancy Widener
Austria
- - Graz, Austria, 8010
    - Recruiting
    - LKH - Universitätsklinikum Graz
    - Contact:
      
      Nancy Widener
  - Neustadt, Austria, 2700
    - Recruiting
    - LK Wiener Neustadt
    - Contact:
      
      Nancy Widener
  - Vienna, Austria, 1090
    - Recruiting
    - Medical University of Vienna
    - Contact:
      
      Nancy Widener
Canada
- - Nova Scotia, Canada, B3H 2Y9
    - Recruiting
    - Queen Elizabeth II Health Sciences Centre
    - Contact:
      
      Nancy Widener
  - Québec, Canada, H4A 3J1
    - Recruiting
    - McGill University Health Centre
    - Contact:
      
      Nancy Widener
- Alberta
  - Calgary, Alberta, Canada, T2N 1N4
    - Recruiting
    - University of Calgary
    - Contact:
      
      Nancy Widener
  - Edmonton, Alberta, Canada, T6G2V2
    - Recruiting
    - University of Alberta Hospital
    - Contact:
      
      Nancy Widener
- Ontario
  - Hamilton, Ontario, Canada, L8V 1C3
    - Recruiting
    - Hamilton Health Sciences, Juravinski Hospital and Cancer Centre
    - Contact:
      
      Nancy Widener
  - Ottawa, Ontario, Canada, K1H BL6
    - Recruiting
    - Ottawa Hospital
    - Contact:
      
      Nancy Widener
  - Saint Catharines, Ontario, Canada, L2S 0A9
    - Recruiting
    - Niagara Health System
    - Contact:
      
      Nancy Widener
  - Sault-Sainte-Marie, Ontario, Canada, P6A 0A8
    - Recruiting
    - Sault Area Hospital
    - Contact:
      
      Nancy Widener
  - Toronto, Ontario, Canada, M5G 2C4
    - Recruiting
    - Toronto General Hospital
    - Contact:
      
      Nancy Widener
- Quebec
  - Montréal, Quebec, Canada, H4A 3J1
    - Recruiting
    - McGill University Health Centre
    - Contact:
      
      Nancy Widener
  - Montréal, Quebec, Canada, H3T-1E2
    - Recruiting
    - Jewish General Hospital
    - Contact:
      
      Nancy Widener
Czechia
- - Brno, Czechia, 65653
    - Recruiting
    - Masarykuv onkologicky ustav
    - Contact:
      
      Nancy Widener
  - Hradec Kralove, Czechia, 50005
    - Recruiting
    - University Hospital Hradec Kralove
    - Contact:
      
      Nancy Widener
  - Nová Ves Pod Pleší, Czechia, 26204
    - Recruiting
    - Nemocnice Na Plesi s.r.o.
    - Contact:
      
      Nancy Widener
  - Prague, Czechia, 128 08
    - Recruiting
    - Onkologická klinika VFN a 1. LF UK
    - Contact:
      
      Nancy Widener
  - Praha, Czechia, 14059
    - Recruiting
    - Thomayerova nemocnice
    - Contact:
      
      Nancy Widener
France
- - Amiens, France, 80057
    - Recruiting
    - CHU Amiens - Hopital Nord
    - Contact:
      
      Nancy Widener
  - Angers, France, 49933
    - Recruiting
    - CHU Angers - Hôpital Hôtel Dieu
    - Contact:
      
      Nancy Widener
  - Brest, France, 29609
    - Recruiting
    - CHU de Brest - Hôpital de la Cavale Blanche
    - Contact:
      
      Nancy Widener
  - Clermont-Ferrand, France, 63003
    - Recruiting
    - CHU Clermont Ferrand - Hopital Gabriel Montpied
    - Contact:
      
      Nancy Widener
  - Colombes, France, 92700
    - Recruiting
    - Hopital Louis Mourier
    - Contact:
      
      Nancy Widener
  - Dijon, France, 21079
    - Recruiting
    - CHU Dijon - Hôpital Bocage Central
    - Contact:
      
      Nancy Widener
  - Grenoble, France, 38043
    - Recruiting
    - CHU de Grenoble - Hôpital Albert Michallon
    - Contact:
      
      Nancy Widener
  - Le Puy-en-Velay, France, 43000
    - Recruiting
    - CH Le Puy en Velay
    - Contact:
      
      Nancy Widener
  - Limoges, France, 87042
    - Recruiting
    - CHU de Limoges - Hôpital Dupuytren
    - Contact:
      
      Nancy Widener
  - Marseille, France, 13385
    - Recruiting
    - Hopital Timone Adultes
    - Contact:
      
      Nancy Widener
  - Morlaix, France, 29600
    - Recruiting
    - Centre hospitalier des pays de Morlaix
    - Contact:
      
      Nancy Widener
  - Paris, France, 75015
    - Recruiting
    - Hopital Europeen Georges Pompidou
    - Contact:
      
      Nancy Widener
  - Paris, France, 75651
    - Recruiting
    - Groupe Hospitalier Pitie-Salpetriere
    - Contact:
      
      Nancy Widener
  - Pierre-Bénite, France, 69310
    - Recruiting
    - Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
    - Contact:
      
      Nancy Widener
  - Rouen, France, 76031
    - Recruiting
    - CHU de Rouen - Hôpital de Bois Guillaume
    - Contact:
      
      Nancy Widener
  - Saint-Étienne, France, 42000
    - Recruiting
    - CHU de Saint-Etienne - Hôpital Nord
    - Contact:
      
      Nancy Widener
  - Strasbourg, France, 67091
    - Recruiting
    - CHU Strasbourg - Nouvel Hopital Civil
    - Contact:
      
      Nancy Widener
  - Strasbourg, France, 67091
    - Recruiting
    - Nouvel Hôpital Civil de Strasbourg
    - Contact:
      
      Nancy Widener
  - Toulon, France, 83000
    - Recruiting
    - Centre Hospitalier Intercommunal de Toulon
    - Contact:
      
      Nancy Widener
  - Toulouse, France, 31059
    - Recruiting
    - CHU de Toulouse - Hôpital Rangueil
    - Contact:
      
      Nancy Widener
  - Vandœuvre-lès-Nancy, France, 54500
    - Recruiting
    - CHU de Nancy - Hôpital de Brabois Adultes
    - Contact:
      
      Nancy Widener
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - CHU de Nancy - Hôpital de Brabois Adultes
    - Contact:
      
      Nancy Widener
Germany
- - Dresden, Germany, 1307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus TU Dresden
    - Contact:
      
      Nancy Widener
  - Dresden, Germany, 1067
    - Recruiting
    - Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
    - Contact:
      
      Nancy Widener
  - Görlitz, Germany, 2827
    - Recruiting
    - Praxis für Gefäßmedizin
    - Contact:
      
      Nancy Widener
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitaetsklinikum Hamburg-Eppendorf
    - Contact:
      
      Nancy Widener
  - Kiel, Germany, 24105
    - Recruiting
    - Universitätsklinik der Christian-Albrechts-Universität
    - Contact:
      
      Nancy Widener
  - Leipzig, Germany, 4103
    - Recruiting
    - Universitätsklinik Leipzig
    - Contact:
      
      Nancy Widener
  - Magdeburg, Germany, 39120
    - Recruiting
    - Universitaetsklinikum Magdeburg A.oe.R
    - Contact:
      
      Nancy Widener
  - Muenchen, Germany, 80336
    - Recruiting
    - Klinikum der Universitaet Muenchen
    - Contact:
      
      Nancy Widener
Hungary
- - Budapest, Hungary, H-1122
    - Recruiting
    - Országos Onkológiai Intézet
    - Contact:
      
      Nancy Widener
  - Debrecen, Hungary, H-4032
    - Recruiting
    - Debreceni Egyetem
    - Contact:
      
      Nancy Widener
  - Eger, Hungary, H-3300
    - Recruiting
    - Markhot Ferenc Oktatokorhaz Es Rendelointezet
    - Contact:
      
      Nancy Widener
  - Kecskemét, Hungary, 6000
    - Recruiting
    - Bács-Kiskun County Hospital
    - Contact:
      
      Nancy Widener
  - Pécs, Hungary, 7624
    - Recruiting
    - University of Pecs
    - Contact:
      
      Nancy Widener
Ireland
- - Cork, Ireland
    - Recruiting
    - Cork University Hospital
    - Contact:
      
      Nancy Widener
  - Cork, Ireland
    - Recruiting
    - Bon Secour Hospital
    - Contact:
      
      Nancy Widener
  - Dublin, Ireland, V2N0
    - Recruiting
    - Beaumont Hospital
    - Contact:
      
      Nancy Widener
  - Dublin, Ireland
    - Recruiting
    - Msdyrt Midericordiae University Hospital
    - Contact:
      
      Nancy Widener
  - Limerick, Ireland, V94 T9PX
    - Recruiting
    - University Hospital, Limerick
    - Contact:
      
      Nancy Widener
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
    - Contact:
      
      Nancy Widener
  - Bologna, Italy, 40133
    - Recruiting
    - Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
    - Contact:
      
      Nancy Widener
  - Castelfranco Veneto, Italy, 31033
    - Recruiting
    - Presidio Ospedaliero di Castelfranco Veneto
    - Contact:
      
      Nancy Widener
  - Chieti, Italy, 66100
    - Recruiting
    - SS. ma Annunziata
    - Contact:
      
      Nancy Widener
  - Cosenza, Italy, 87100
    - Recruiting
    - Ospedale Civile Dell Annunziata
    - Contact:
      
      Nancy Widener
  - Faenza, Italy, 48018
    - Recruiting
    - Ospedale Degli Infermi
    - Contact:
      
      Nancy Widener
  - Genova, Italy, 16132
    - Recruiting
    - Azienda Ospedaliero Universitaria San Martino
    - Contact:
      
      Nancy Widener
  - Grosseto, Italy, 58100
    - Recruiting
    - Presidio Ospedaliero della Misericordia
    - Contact:
      
      Nancy Widener
  - Milano, Italy, 20142
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo
    - Contact:
      
      Nancy Widener
  - Modena, Italy, 41124
    - Recruiting
    - A.O.U. Policlinico di Modena
    - Contact:
      
      Nancy Widener
  - Napoli, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori Fondazione G. Pascale
    - Contact:
      
      Nancy Widener
  - Padova, Italy, 35128
    - Recruiting
    - Azienda Ospedale - Università Padova
    - Contact:
      
      Nancy Widener
  - Parma, Italy, 43100
    - Recruiting
    - Azienda Ospedaliero Universitaria di Parma
    - Contact:
      
      Nancy Widener
  - Perugia, Italy, 6132
    - Recruiting
    - Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia
    - Contact:
      
      Nancy Widener
  - Pisa, Italy, 56126
    - Recruiting
    - Azienda Ospedaliero Universitaria Pisana
    - Contact:
      
      Nancy Widener
  - Reggio Emilia, Italy, 42123
    - Recruiting
    - Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
    - Contact:
      
      Nancy Widener
  - Roma, Italy, 168
    - Recruiting
    - Fondazione Policlinico Universitario A. Gemelli IRCCS.
    - Contact:
      
      Nancy Widener
  - Rozzano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Nancy Widener
  - Treviso, Italy, 35128
    - Recruiting
    - Ospedale Santa Maria di Cà Foncello
    - Contact:
      
      Nancy Widener
  - Udine, Italy, 33100
    - Recruiting
    - Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
    - Contact:
      
      Nancy Widener
  - Varese, Italy, 21100
    - Recruiting
    - Università dell'Insubria
    - Contact:
      
      Nancy Widener
  - Venezia, Italy, 30122
    - Recruiting
    - Ospedale SS. Giovanni e Paolo
    - Contact:
      
      Nancy Widener
  - Verduno, Italy, 12060
    - Recruiting
    - Ospedalemichele e Pietro ferrer
    - Contact:
      
      Nancy Widener
  - Vicenza, Italy, 36100
    - Recruiting
    - Ospedale San Bortolo di Vicenza
    - Contact:
      
      Nancy Widener
Japan
- - Chiba, Japan, 275-0006
    - Recruiting
    - Chibaken Saiseikai Narashino Hospital
    - Contact:
      
      Nancy Widener
  - Isehara, Japan, 259-1193
    - Recruiting
    - Tokai University Hospital
    - Contact:
      
      Nancy Widener
  - Kobe, Japan, 650-0017
    - Recruiting
    - Kobe University Hospital
    - Contact:
      
      Nancy Widener
  - Kyoto, Japan, 606-8507
    - Recruiting
    - Kyoto University Hospital
    - Contact:
      
      Nancy Widener
  - Mie, Japan, 514-8507
    - Recruiting
    - Mie University Hospital
    - Contact:
      
      Nancy Widener
  - Minato-Ku, Japan, 108-0073
    - Recruiting
    - Tokyo Saiseikai Central Hospital
    - Contact:
      
      Nancy Widener
  - Miyagi, Japan, 980-8574
    - Recruiting
    - Tohoku University Graduate School of Medicine
    - Contact:
      
      Nancy Widener
  - Okayama, Japan, 7011192
    - Recruiting
    - Okayama Medical Center
    - Contact:
      
      Nancy Widener
  - Osaka, Japan, 541-8567
    - Recruiting
    - Osaka International Cancer Institute
    - Contact:
      
      Nancy Widener
  - Tokyo, Japan, 108-8329
    - Recruiting
    - International University of Health and Welfare Mita Hospital
    - Contact:
      
      Nancy Widener
  - Tokyo, Japan, 113-8421
    - Recruiting
    - Juntendo University Hospital
    - Contact:
      
      Nancy Widener
Korea, Republic of
- - Anyang, Korea, Republic of, 14068
    - Recruiting
    - Hallym University Sacred Heart Hospital
    - Contact:
      
      Nancy Widener
  - Bucheon, Korea, Republic of, 14584
    - Recruiting
    - SoonChunHyang University Hospital Bucheon
    - Contact:
      
      Nancy Widener
  - Daegu, Korea, Republic of, 42472
    - Recruiting
    - Daegu Catholic University Medical Center
    - Contact:
      
      Nancy Widener
  - Gangdong, Korea, Republic of, 05278
    - Recruiting
    - Kyung Hee University Hospital at Gangdong
    - Contact:
      
      Nancy Widener
  - Jeonju, Korea, Republic of, 54907
    - Recruiting
    - Jeonbuk National University Hospital
    - Contact:
      
      Nancy Widener
  - Seogu, Korea, Republic of, 49201
    - Recruiting
    - Dong-A University Hospital
    - Contact:
      
      Nancy Widener
  - Seoul, Korea, Republic of, 4401
    - Recruiting
    - SoonChunHyang University Seoul Hospital
    - Contact:
      
      Nancy Widener
  - Yangcheon, Korea, Republic of, 07985
    - Recruiting
    - Ewha Womans University Mokdong Hospital
    - Contact:
      
      Nancy Widener
  - Yongsan, Korea, Republic of, 04401
    - Recruiting
    - SoonChunHyang University Seoul Hospital
    - Contact:
      
      Nancy Widener
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
    - Recruiting
    - Myongji Hospital
    - Contact:
      
      Nancy Widener
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Nancy Widener
  - Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
    - Recruiting
    - Yongin Severance Hospital, Yonsei University Health System
    - Contact:
      
      Nancy Widener
Latvia
- - Daugavpils, Latvia, LV-5417
    - Recruiting
    - Daugavpils Regional Hospital
    - Contact:
      
      Nancy Widener
  - Liepāja, Latvia, LV3414
    - Recruiting
    - Liepaja Regional Hospital
    - Contact:
      
      Nancy Widener
  - Riga, Latvia, LV-1002
    - Recruiting
    - Pauls Stradins Clinical University Hospital
    - Contact:
      
      Nancy Widener
  - Riga, Latvia, LV1079
    - Recruiting
    - Riga East University Hospital
    - Contact:
      
      Nancy Widener
Netherlands
- - Amersfoort, Netherlands, 3813
    - Recruiting
    - Meander Medisch Centrum
    - Contact:
      
      Nancy Widener
  - Amersfoort, Netherlands, 1066 EC
    - Recruiting
    - Meander Medisch Centrum
    - Contact:
      
      Nancy Widener
  - Amsterdam, Netherlands, 1091
    - Recruiting
    - Onze Lieve Vrouwe Gasthuis, locatie Oost
    - Contact:
      
      Nancy Widener
  - Amsterdam, Netherlands, 1091 AC
    - Recruiting
    - Onze Lieve Vrouwe Gasthuis, locatie Oost
    - Contact:
      
      Nancy Widener
  - Beverwijk, Netherlands, 1942
    - Recruiting
    - Rode Kruis Ziekenhuis
    - Contact:
      
      Nancy Widener
  - Den Haag, Netherlands, 2545 AA
    - Recruiting
    - Haga ziekenhuis
    - Contact:
      
      Nancy Widener
  - Dordrecht, Netherlands, 3317
    - Recruiting
    - Albert Schweitzer Ziekenhuis, Dordwijk
    - Contact:
      
      Nancy Widener
  - Groningen, Netherlands, 9713
    - Recruiting
    - Universitair Medisch Centrum Groningen
    - Contact:
      
      Nancy Widener
  - Hilversum, Netherlands, 1213
    - Recruiting
    - Tergooiziekenhuizen, Hilversum
    - Contact:
      
      Nancy Widener
  - Holland, Netherlands, 1105AZ
    - Recruiting
    - Amsterdam University Medical Center
    - Contact:
      
      Nancy Widener
  - Hoofddorp, Netherlands, 2134TM
    - Recruiting
    - Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid
    - Contact:
      
      Nancy Widener
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leids Universitair Medisch Centrum
    - Contact:
      
      Nancy Widener
  - Nijmegen, Netherlands, 6525
    - Recruiting
    - Radboud Universitair Medisch Centrum
    - Contact:
      
      Nancy Widener
  - Rotterdam, Netherlands, 3083 AN
    - Recruiting
    - Ikazia Ziekenhuis
    - Contact:
      
      Nancy Widener
Norway
- - Fredrikstad, Norway, 1603
    - Recruiting
    - Østfold Hospital Kalnes
    - Contact:
      
      Nancy Widener
  - Lørenskog, Norway, 1478
    - Recruiting
    - Akershus Univeristy Hospital
    - Contact:
      
      Nancy Widener
  - Oslo, Norway, 0372
    - Recruiting
    - Oslo University Hospital, Dep of Haematology
    - Contact:
      
      Nancy Widener
Spain
- - Barcelona, Spain, 8041
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
    - Contact:
      
      Nancy Widener
  - Barcelona, Spain, 8036
    - Recruiting
    - Hospital Clinic de Barcelona
    - Contact:
      
      Nancy Widener
  - Barcelona, Spain, 8035
    - Recruiting
    - Complejo Hospital Vall D'Heborn
    - Contact:
      
      Nancy Widener
  - Elche, Spain, 03001
    - Recruiting
    - Hospital Universitario del Vinalopó
    - Contact:
      
      Nancy Widener
  - Elche, Spain, 3203
    - Recruiting
    - Hospital General Universitario de Elche
    - Contact:
      
      Nancy Widener
  - Granada, Spain, 18014
    - Recruiting
    - Hospital Universitario Virgen de Las Nieves
    - Contact:
      
      Nancy Widener
  - Jaén, Spain, 23007
    - Recruiting
    - Hospital Universitario Ciudad de Jaen
    - Contact:
      
      Nancy Widener
  - Lugo, Spain, 27003
    - Recruiting
    - Hospital Universitario Lucus Augusti
    - Contact:
      
      Nancy Widener
  - Madrid, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor
    - Contact:
      
      Nancy Widener
  - Madrid, Spain, 28027
    - Recruiting
    - Clinica Universidad de Navarra
    - Contact:
      
      Nancy Widener
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Maranon
    - Contact:
      
      Nancy Widener
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Clinico San Carlos
    - Contact:
      
      Nancy Widener
  - Madrid, Spain, 28033
    - Recruiting
    - MD Anderson Cancer Centre
    - Contact:
      
      Nancy Widener
  - Majadahonda, Spain, 28220
    - Recruiting
    - Hospital Universitario Puerta de Hierro Majadahonda
    - Contact:
      
      Nancy Widener
  - Ourense, Spain, 32005
    - Recruiting
    - Complejo Hospitalario Universitario de Orense
    - Contact:
      
      Nancy Widener
  - Pamplona, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra
    - Contact:
      
      Nancy Widener
  - Sabadell, Spain, 8208
    - Recruiting
    - Corporació Sanitària Parc Taulí
    - Contact:
      
      Nancy Widener
  - Santander, Spain, 39012
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
    - Contact:
      
      Nancy Widener
  - Santiago De Compostela, Spain, 15706
    - Recruiting
    - Complejo Hospitalario Universitario de Santiago
    - Contact:
      
      Nancy Widener
  - Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocío
    - Contact:
      
      Nancy Widener
Sweden
- - Sundsvall, Sweden, 85186
    - Recruiting
    - Länssjukhuset Sundsvall-Härnösand
    - Contact:
      
      Nancy Widener
Switzerland
- - Geneve, Switzerland, 1205
    - Recruiting
    - Hopital Universitaire Geneve
    - Contact:
      
      Nancy Widener
  - Lausanne, Switzerland, 1011
    - Recruiting
    - Centre Hospitalier Universitaire Vaudois
    - Contact:
      
      Nancy Widener
  - Zürich, Switzerland, 8091
    - Recruiting
    - University of Zurich
    - Contact:
      
      Nancy Widener
Taiwan
- - Kaohsiung, Taiwan, 807
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
    - Contact:
      
      Nancy Widener
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Far Eastern Memorial Hospital
    - Contact:
      
      Nancy Widener
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital
    - Contact:
      
      Nancy Widener
  - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital
    - Contact:
      
      Nancy Widener
  - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospital
    - Contact:
      
      Nancy Widener
  - Taipei, Taiwan, 114
    - Recruiting
    - Tri-Service General Hospital
    - Contact:
      
      Nancy Widener
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Nancy Widener
  - Taipei, Taiwan, 112
    - Recruiting
    - Koo Foundation Sun Yat-Sen Cancer Center
    - Contact:
      
      Nancy Widener
United Kingdom
- ENG
  - Cottingham, ENG, United Kingdom, HU16 5JQ
    - Recruiting
    - Castle Hill Hospital, Department of Oncology & Haematology
    - Contact:
      
      Nancy Widener
  - London, ENG, United Kingdom, E1 188
    - Recruiting
    - Barts Health NHS Trust
    - Contact:
      
      Nancy Widener
  - Newcastle upon Tyne, ENG, United Kingdom, NE7 7DN
    - Recruiting
    - The Newcastle Upon Tyne Hospitals
    - Contact:
      
      Nancy Widener
- England
  - Cardiff, England, United Kingdom, CF14 4XW
    - Recruiting
    - University Hospital of Wales
    - Contact:
      
      Nancy Widener
  - Stafford, England, United Kingdom, ST16 3SA
    - Recruiting
    - University Hospitals of North Midlands
    - Contact:
      
      Nancy Widener
  - Stoke-on-Trent, England, United Kingdom, ST4 6QG
    - Recruiting
    - University Hospitals of North Midlands
    - Contact:
      
      Nancy Widener
- SCO
  - Glasgow, SCO, United Kingdom, G514TF
    - Recruiting
    - Queen Elizabeth University Hospital Campus
    - Contact:
      
      Nancy Widener
United States
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Anschutz Medical Campus
    - Contact:
      
      Nancy Widener
- Connecticut
  - West Haven, Connecticut, United States, 06516-5907
    - Recruiting
    - VA Connecticut Healthcare System
    - Contact:
      
      Nancy Widener
- District of Columbia
  - Washington, District of Columbia, United States, 20422
    - Recruiting
    - Washington DC VAMC
    - Contact:
      
      Nancy Widener
- Florida
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Health
    - Contact:
      
      Nancy Widener
- Illinois
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - Northshore University Health System
    - Contact:
      
      Nancy Widener
- Kentucky
  - Lexington, Kentucky, United States, 40536-0093
    - Recruiting
    - University of Kentucky, Markey Cancer Center
    - Contact:
      
      Nancy Widener
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
    - Contact:
      
      Nancy Widener
  - Boston, Massachusetts, United States, 02215-5400
    - Recruiting
    - Beth Israel Deaconess Medical Center
    - Contact:
      
      Nancy Widener
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System
    - Contact:
      
      Nancy Widener
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University
    - Contact:
      
      Nancy Widener
- New York
  - New York, New York, United States, 10021-0005
    - Recruiting
    - Memorial Sloan Kettering Cancer Center
    - Contact:
      
      Nancy Widener
  - Rochester, New York, United States, 14621
    - Recruiting
    - Lipson Cancer Institute
    - Contact:
      
      Nancy Widener
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center
    - Contact:
      
      Nancy Widener
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic Foundation
    - Contact:
      
      Nancy Widener
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - University of Oklahoma Health Sciences Center
    - Contact:
      
      Nancy Widener
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Temple University Hospital
    - Contact:
      
      Nancy Widener
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania - Penn Blood Disorders Center
    - Contact:
      
      Nancy Widener
- Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - MD Anderson Cancer Center
    - Contact:
      
      Nancy Widener
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - University of Texas Mays Cancer Center
    - Contact:
      
      Nancy Widener
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Sentara Norfolk General Hospital
    - Contact:
      
      Nancy Widener
- Wisconsin
  - La Crosse, Wisconsin, United States, 54601
    - Recruiting
    - Gundersen Health System
    - Contact:
      
      Nancy Widener
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Blood Center of Wisconsin
    - Contact:
      
      Nancy Widener

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
Confirmed diagnosis of cancer (by histology, adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:
- Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization and/or
- Currently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava [IVC] thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery.

Patients are eligible within 120 hours from diagnosis of the qualifying VTE

Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated
Able to provide written informed consent

Exclusion Criteria:

Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) DVT and/or PE
More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
An indication to continue treatment with therapeutic doses of an anticoagulant other than that VTE treatment prior to randomization (e.g., atrial fibrillation [AF], mechanical heart valve, prior VTE)
Platelet count <50,000/mm3 at the screening visit
PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or shock)
Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within the 4 weeks preceding screening
Brain trauma or a cerebral or spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
Need for aspirin in a dosage of >100 mg/day or any other antiplatelet agent alone or in combination with aspirin
Primary brain cancer or untreated intracranial metastases at baseline
Acute myeloid or lymphoid leukemia
Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
Life expectancy <3 months at randomization
Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation) at the screening visit
Hemoglobin <8 g/dL at the screening visit
Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) at the screening visit in absence of clinical explanation
Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of apixaban or 100 days after administration of abelacimab (See Section 5.3.6. for highly effective contraceptive measures)
Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of apixaban or 100 days after administration of abelacimab
Pregnant or breast-feeding women
Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P gp
History of hypersensitivity to any of the study drugs (including apixaban) or excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
Subjects with any condition that in the Investigator's judgement would place the subject at increased risk of harm if he/she participated in the study
Use of other investigational (not registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic(s) (PD) effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abelacimab Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously	Biological: Abelacimab Abelacimab 150 mg Other Names: MAA868
Active Comparator: Apixaban Apixaban administered orally twice a day	Drug: Apixaban Apixaban 10 mg followed by 5 mg Other Names: Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events Time Frame: 6 months	6 months
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthos Therapeutics, Inc.

Collaborators

Itreas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ANT-007
2021-003076-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Venous Thromboembolism

Clinical Trials on Abelacimab

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