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

PHASE3RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-05-05

Primary completion: 2026-12-01

Study completion finish: 2027-02-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05171049

Intervention or treatment

BIOLOGICAL: Abelacimab

DRUG: Apixaban

Conditions

• Venous Thromboembolism
• Deep Venous Thrombosis
• Pulmonary Embolism

Condition: Venous Thromboembolism, Deep Venous Thrombosis and more
BIOLOGICAL: Abelacimab and other drugs
Blacktown, New South Wales, Australia and more
Sponsor: Anthos Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Blacktown Hospital

Research sites nearby

Select from list below to view details:

Blacktown Hospital
Blacktown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Abelacimab Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously	BIOLOGICAL: Abelacimab Abelacimab 150 mg
ACTIVE_COMPARATOR: Apixaban Apixaban administered orally twice a day	DRUG: Apixaban Apixaban 10 mg followed by 5 mg

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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	Not Specified	6 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events	Not Specified	6 months
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding	Not Specified	6 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE