A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
NCT ID: NCT05171075
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
417 participants
INTERVENTIONAL
2022-09-27
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Abelacimab
Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
Abelacimab
Abelacimab 150 mg
Dalteparin
Dalteparin administered subcutaneously daily
Dalteparin
Dalteparin 200 IU/kg/day followed by 150 IU/kg/day
Interventions
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Abelacimab
Abelacimab 150 mg
Dalteparin
Dalteparin 200 IU/kg/day followed by 150 IU/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers if:
* Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
* No intended curative surgery during the study
* Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein 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 LMWH for at least 6 months is indicated
* Able to provide written informed consent
Exclusion Criteria
* More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
* An indication to continue treatment with therapeutic doses of an anticoagulant other than for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
* PE leading to hemodynamic instability (systolic BP \<90 mmHg or shock).
* Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
* Brain trauma, or cerebral or a 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 more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
* 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
* History of heparin induced thrombocytopenia
* Infective acute or subacute endocarditis at the time of presentation
* Primary brain cancer or untreated intracranial metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
* Life expectancy of \<3 months at randomization
* Calculated creatinine clearance (CrCl) \<30 mL/min at the screening visit
* Platelet count \<50,000/ mm3 at the screening visit
* Hemoglobin \<8 g/dL at the screening visit
* Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase ≥3 times and/or bilirubin ≥2 times the upper limit of normal (ULN) at the screening visit in the absence of clinical explanation
* Uncontrolled hypertension (systolic blood pressure \[BP\] \> 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 dalteparin or 100 days after administration of abelacimab
* 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 dalteparin or 100 days after administration of abelacimab
* Pregnant or breast-feeding women
* History of hypersensitivity to any of the study drugs (including dalteparin) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for dalteparin
* Subjects with any condition that in the judgement of the Investigator 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 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Anthos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Washington DC VAMC
Washington D.C., District of Columbia, United States
NorthShore University Health System
Evanston, Illinois, United States
Barnes-Jewish Hospital
St 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
Blacktown Hospital
Blacktown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Northern Health
Epping, Victoria, Australia
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
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
Nanfang Hospital of Southern Medical University
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
Huizhou Municipal Central Hospital
Huizhou, , China
Nanjing First Hospital
Nanjing, , China
Nantong Tumor Hospital (Tumor Hospital Affiliated to Nantong University )
Tongzhou, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , 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
Onkologická klinika VFN a 1. LF UK
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
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
Nouvel Hôpital Civil de Strasbourg
Strasbourg, Strasbourg, France
CHU Angers - Hôpital Hôtel Dieu
Angers, , France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , 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-Etienne, , France
CHU Strasbourg - Nouvel Hôpital Civil
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 Leipzig
Leipzig, , Germany
Debreceni Egyetem
Debrecen, , Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, , Hungary
Cork University Hospital
Cork, , Ireland
Bon Secour Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
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 Socio Sanitaria Territoriale Santi Paolo e Carlo
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Azienda Ospedale - Università Padova
Padua, , Italy
Ospedale Universitario
Padua, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale San Bortolo di Vicenza
Vicenza, , Italy
Daugavpils Regional Hospital
Daugavpils, , Latvia
Liepaja Regional Hospital
Liepāja, , Latvia
Pauls Stradins CUH
Riga, , Latvia
Meander Medisch Centrum
Amersfoort, , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, , Netherlands
Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid
Haarlem, , Netherlands
Amsterdam University Medical Center
Holland, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
Østfold Hospital Kalnes
Fredrikstad, , Norway
Akershus Univeristy Hospital
Lørenskog, , Norway
Jeonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Hospital Universitario Del Vinalopo
Alicante, , 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
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
Hospital Universitario Virgen del Rocio
Seville, , Spain
Länssjukhuset Sundsvall-Härnösand
Sundsvall, , Sweden
Hopital Universitaire Geneve
Geneva, , Switzerland
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Cheng Kung University (NCKU) Hospital
Tainan, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
University Hospital of Wales
Cardiff, 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
Countries
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Other Identifiers
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2021-003085-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMAA868D12301
Identifier Type: OTHER
Identifier Source: secondary_id
ANT-008
Identifier Type: -
Identifier Source: org_study_id