A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

NCT05171075 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: ANT-0082021-003085-12CMAA868D12301
• Study Type: interventional
• Target: 417
• Locations: 19 countries
• Sites: 115

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)

Conditions

Venous Thromboembolism; Pulmonary Embolism; Deep Venous Thrombosis

Keywords

Anticoagulants; VTE recurrence rate; PROBE design; LMWH; CAT; Cancer associated VTE; GI cancer; Abelacimab; Dalteparin; GU cancer; FXI; Major bleeding events; CRNM bleeding events

Outcome Measures

Primary Outcomes (1)

• Time to first event of centrally adjudicated VTE recurrence

  Time to first adjudicated venous thromboembolism (VTE) event recurrence

  up to 6 months

Secondary Outcomes (8)

• Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events

  up to 6 months

• Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated CRNM bleeding events

  up to 6 months

• Time to event of permanent treatment discontinuation not due to death

  up to 6 months

• Time to first event of ISTH-adjudicated CRNM bleeding events

  up to 6 months

• Time to first event of ISTH-adjudicated major bleeding events

  Up to 6 months

Study Arms (2)

Abelacimab

EXPERIMENTAL

Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Biological: Abelacimab

Dalteparin

ACTIVE COMPARATOR

Dalteparin administered subcutaneously daily

Drug: Dalteparin

Interventions

Abelacimab BIOLOGICAL

Abelacimab 150 mg

Also known as: MAA868

Abelacimab

Dalteparin DRUG

Dalteparin 200 IU/kg/day followed by 150 IU/kg/day

Also known as: Fragmin

Dalteparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
• 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

You may not qualify if:

• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
• 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

Sponsors & Collaborators

• Anthos Therapeutics, Inc.: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (117)

Washington DC VAMC

Washington D.C., District of Columbia, 20422, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center-Middletown

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center-Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center-West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021-0005, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Northern Health

Epping, Victoria, 3076, Australia

Location

LK Wiener Neustadt

Neustadt, 2700, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Hamilton Health Sciences, Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa Hospital Research Instituite

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital Research Instituite

Ottawa, Ontario, K1H BL6, Canada

Location

University of Calgary

Calgary, T2N1N4, Canada

Location

Sault Area Hospital

Marie, P6A0A8, Canada

Location

Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

Beijing Shijitan Hosp.

Beijing, 100038, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Jilin Province Tumor Hospital

Ch’ang-ch’un, 130012, China

Location

Southern Medical University - Zhujiang Hospital

Guangdong, 510280, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, 510515, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510655, China

Location

Huizhou Municipal Central Hospital

Huizhou, 516001, China

Location

Nanjing First Hospital

Nanjing, 210006, China

Location

Nantong Tumor Hospital (Tumor Hospital Affiliated to Nantong University )

Tongzhou, 226361, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

Union Hospital Tongji Medical College Huazhong University of Science &Technology

Wuhan, 430023, China

Location

Hubei Cancer Hospital

Wuhan, 430079, China

Location

The Second Hospital of Jiaxing

Zhejiang, 314000, China

Location

Masarykuv onkologicky ustav

Brno, 65653, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Onkologická klinika VFN a 1. LF UK

Prague, 128 08, Czechia

Location

Thomayerova nemocnice

Prague, 14059, Czechia

Location

CHU de Limoges - Hôpital Dupuytren

Limoges, Cedex, 87042, France

Location

CH Le Puy en Velay

Le Puy-en-Velay, Chantemesse, 43 000, France

Location

Hôpital Louis Mourier

Colombes, Renouiflers, 92700, France

Location

CHU de Nancy - Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, Rue Du Morvan, 54500, France

Location

Nouvel Hôpital Civil de Strasbourg

Strasbourg, Strasbourg, 67091, France

Location

CHU Angers - Hôpital Hôtel Dieu

Angers, 49933, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU de Limoges - Hôpital Dupuytren

Limoges, 87042, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69310, France

Location

CHU de Rouen - Hôpital de Bois Guillaume

Rouen, 76031, France

Location

CHU de Saint-Etienne - Hopital Nord

Saint-Etienne, 42000, France

Location

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Centre Hospitalier Intercommunal de Toulon

Toulon, 83000, France

Location

CHU de Nancy - Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 1307, Germany

Location

Praxis für Gefäßmedizin

Görlitz, 2827, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinik Leipzig

Leipzig, 4103, Germany

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, H-3300, Hungary

Location

Cork University Hospital

Cork, T12 DC4A, Ireland

Location

Bon Secour Hospital

Cork, T12 DV56, Ireland

Location

Beaumont Hospital

Dublin, D09V2N0, Ireland

Location

IRCCS Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

Bologna, 40133, Italy

Location

Presidio Ospedaliero di Castelfranco Veneto

Castelfranco Veneto, 31033, Italy

Location

SS. ma Annunziata

Chieti, 66013, Italy

Location

Ospedale Civile Dell Annunziata

Cosenza, 87100, Italy

Location

Ospedale Degli Infermi

Faenza, 48018, Italy

Location

Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo

Milan, 20142, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy

Location

Azienda Ospedale - Università Padova

Padova, 35128, Italy

Location

Ospedale Universitario

Padova, 35128, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Ospedale San Bortolo di Vicenza

Vicenza, 36100, Italy

Location

Daugavpils Regional Hospital

Daugavpils, LV-5417, Latvia

Location

Liepaja Regional Hospital

Liepāja, LV3414, Latvia

Location

Pauls Stradins CUH

Riga, LV-1002, Latvia

Location

Meander Medisch Centrum

Amersfoort, 3813, Netherlands

Location

Albert Schweitzer Ziekenhuis, Dordwijk

Dordrecht, 3317 NM, Netherlands

Location

Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid

Haarlem, Netherlands

Location

Amsterdam University Medical Center

Holland, 1105AZ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6500, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Haga Ziekenhuis

The Hague, 2545 AA, Netherlands

Location

Østfold Hospital Kalnes

Fredrikstad, 1603, Norway

Location

Akershus Univeristy Hospital

Lørenskog, 1478, Norway

Location

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 7985, South Korea

Location

Hospital Universitario Del Vinalopo

Alicante, 03293, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital General Universitario de Elche

Elche, 3203, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Ciudad de Jaen

Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Complejo Hospitalario Universitario de Ourense

Ourense, Spain

Location

Hospital Universitario Central de Asturia

Oviedo, 33011, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 8208, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39012, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Länssjukhuset Sundsvall-Härnösand

Sundsvall, 85186, Sweden

Location

Hopital Universitaire Geneve

Geneva, 1205, Switzerland

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

National Cheng Kung University (NCKU) Hospital

Tainan, 704, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

University Hospital of Wales

Cardiff, England, CF14 4XW, United Kingdom

Location

Castle Hill Hospital, Department of Oncology & Haematology

Cottingham, ENG, HU16 5JQ, United Kingdom

Location

The Newcastle Upon Tyne Hospitals

Newcastle upon Tyne, ENG, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Gastrointestinal Neoplasms

Interventions

abelacimab; MAA868; Dalteparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 28, 2021
• Study Start: September 27, 2022
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (16); IE (3); CZ (4); CH (1); ES (16); TW (3); LA (3); DE (5); SE (1); HU (2); US (10); CN (13); NL (8); IT (13); KR (3); CA (6); AU (3); GB (3); NO (2)