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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05171075
Recruitment Status : Recruiting
First Posted : December 28, 2021
Last Update Posted : April 12, 2023
Sponsor:
Collaborator:
Itreas
Information provided by (Responsible Party):
Anthos Therapeutics, Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism Biological: Abelacimab Drug: Dalteparin Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 27, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : January 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Abelacimab
Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
 Biological: Abelacimab
Abelacimab 150 mg
Other Name: MAA868
Active Comparator: Dalteparin
Dalteparin administered subcutaneously daily
 Drug: Dalteparin
Dalteparin 200 IU/kg/day followed by 150 IU/kg/day
Other Name: Fragmin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 acute 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 72 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:

  • 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 72 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 in the 4 weeks preceding 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 major surgery at baseline
  • History of heparin induced thrombocytopenia
  • 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
  • Platelet count <50,000/ mm3
  • Hemoglobin <8 g/dL
  • Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase ≥3 times and/or bilirubin ≥2 times the upper limit of normal 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05171075


Contacts
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Contact: Nancy Widener 239-284-3741 Nancy.w@anthostherapeutics.com
Contact: Deb Freedholm 609-439-8246 Deb.f@anthostherapeutics.com

Locations
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Sponsors and Collaborators
Anthos Therapeutics, Inc.
Itreas
More Information
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Responsible Party: Anthos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05171075    
Other Study ID Numbers: ANT-008
2021-003085-12 ( EudraCT Number )
First Posted: December 28, 2021    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthos Therapeutics, Inc.:
Anticoagulants
VTE recurrence rate
PROBE design
LMWH
CAT
Cancer associated VTE
GI cancer
 Abelacimab
Dalteparin
GU cancer
FXI
Major bleeding events
CRNM bleeding events
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Dalteparin
Tinzaparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action