ACTIVE_NOT_RECRUITING

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

Conditions

Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism Anticoagulants VTE recurrence rate PROBE design LMWH CAT Cancer associated VTE Abelacimab Apixaban FXI Major bleeding events CRNM bleeding events

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2022-05-05

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05171049

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

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

* 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

Contacts and Locations

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

VA Connecticut Healthcare System

West Haven, Connecticut, 06516-5907

United States

Washington DC VAMC

Washington D.C., District of Columbia, 20422

United States

University of Miami Health

Miami, Florida, 33136

United States

NorthShore University Health System

Evanston, Illinois, 60201

United States

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536-0093

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5400

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Washington University

St Louis, Missouri, 63110

United States

Memorial Sloan Kettering Cancer Center-Middletown

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Cancer Center-Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Cancer Center-West Harrison

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021-0005

United States

Lipson Cancer Institute

Rochester, New York, 14621

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

University of Pennsylvania - Penn Blood Disorders Center

Philadelphia, Pennsylvania, 19104

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Texas Mays Cancer Center

San Antonio, Texas, 78229

United States

Gundersen Health System

La Crosse, Wisconsin, 54601

United States

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Anthos Therapeutics, Inc.

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 Registration Dates

Study Start Date2022-05-05

Study Completion Date2027-02

Study Record Updates

Study Start Date2022-05-05

Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

Anticoagulants
VTE recurrence rate
PROBE design
LMWH
CAT
Cancer associated VTE
Abelacimab
Apixaban
FXI
Major bleeding events
CRNM bleeding events

Additional Relevant MeSH Terms

Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolism