Abelacimab vs Apixaban for Cancer-Related Blood Clots

(ASTER Trial)

Recruiting at207 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Anthos Therapeutics, Inc.

Must be taking: DOACs

Must not be taking: Antiplatelets

Disqualifiers: Thrombectomy, Brain cancer, Leukemia, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing abelacimab, a medication, to prevent blood clots in cancer patients who have had previous clots. It aims to see if it works better and causes fewer bleeding problems compared to a current treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you do not have an indication to continue treatment with other anticoagulants. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Abelacimab or Apixaban for cancer-related blood clots?

Research shows that Apixaban, a drug similar to Abelacimab, is effective in preventing blood clots in cancer patients without increasing major bleeding risks. Additionally, Apixaban has been shown to be effective in other conditions like atrial fibrillation, suggesting its potential usefulness in treating cancer-related blood clots. ^{1 2 3 4 5}

Is Apixaban generally safe for humans?

Apixaban (Eliquis) is generally considered safe for humans and has been approved for preventing blood clots after hip or knee replacement surgery and for treating venous thromboembolism (VTE). Studies have shown that patients using Apixaban did not experience significantly more bleeding complications compared to those not on anticoagulation therapy. ^{1 2 3 6 7}

How is the drug Abelacimab different from other treatments for cancer-related blood clots?

Abelacimab is unique because it targets Factor XI, a protein involved in blood clotting, which may offer a different approach compared to other anticoagulants like Apixaban that inhibit Factor Xa. This novel mechanism could potentially reduce the risk of bleeding while effectively preventing blood clots in cancer patients. ^{1 5 7 8 9}

Research Team

Eligibility Criteria

Adults diagnosed with cancer-associated venous thromboembolism (VTE), including deep vein thrombosis or pulmonary embolism, can join this trial if they've been diagnosed within the past 120 hours and need blood thinners for at least 6 months. They must not have used certain treatments for VTE, have specific medical conditions, or be on conflicting medications.

Inclusion Criteria

I have been on a blood thinner medication for at least 6 months.

I have a blood clot in my leg or lungs.

I was diagnosed with a blood clot less than 120 hours ago.

Exclusion Criteria

I need to keep taking a blood thinner for reasons other than blood clots.

I have had a procedure or treatment for a blood clot in my veins.

I do not have severe medical conditions like recent major bleeding, serious heart issues, or planned major surgeries.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either abelacimab intravenously followed by monthly subcutaneous administration or apixaban orally twice daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abelacimab (Monoclonal Antibodies)
• Apixaban (Anticoagulant)

Trial Overview The study is testing Abelacimab against Apixaban to see which is better at preventing VTE from coming back and causing less bleeding in patients with cancer-related VTE. It's a Phase 3 trial where participants are randomly chosen to receive one of the two drugs.

Participant Groups

Group I: Abelacimab Experimental Treatment 1 Intervention

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

Group II: Apixaban Active Control 1 Intervention

Apixaban administered orally twice a day

Who Is Running the Clinical Trial?

Anthos Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

6,600+

Itreas

Collaborator

Trials

2

Recruited

2,700+

Findings from Research

In a study of 280 metastatic melanoma patients treated with immune checkpoint inhibitors (ICI), those receiving the oral FXa inhibitor rivaroxaban showed significantly improved clinical outcomes, including higher complete response rates and better progression-free survival compared to those not on FXa inhibitors.

Patients on anticoagulation during ICI therapy did not experience increased bleeding complications, suggesting that FXa inhibitors can be safely combined with ICI therapy to potentially enhance anti-tumor immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticoagulation with Factor Xa Inhibitors Is Associated with Improved Overall Response and Progression-Free Survival in Patients with Metastatic Malignant Melanoma Receiving Immune Checkpoint Inhibitors-A Retrospective, Real-World Cohort Study. Haist, M., Stege, H., Pemler, S., et al.[2021]

Apixaban is a highly selective factor Xa inhibitor that demonstrated potent anticoagulant properties in vitro, with a very low inhibition constant (K(i)) of 0.08 nm for human FXa, indicating its effectiveness in preventing blood clots.

In rabbit models, apixaban effectively prevented thrombosis at doses that did not significantly affect bleeding time, suggesting it can reduce clot formation while maintaining normal hemostasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. Wong, PC., Crain, EJ., Xin, B., et al.[2023]

A reliable and sensitive method was developed to measure apixaban and its major metabolite in human plasma, which is crucial for clinical testing and monitoring of this anticoagulant drug.

The method showed excellent precision and accuracy, with low limits of quantification, making it effective for supporting clinical studies involving apixaban.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column. Pursley, J., Shen, JX., Schuster, A., et al.[2022]

Apixaban is effective for treating venous thromboembolism (VTE) in cancer patients, demonstrating significant efficacy in reducing the risk of recurrent blood clots.

The study highlights the safety of apixaban, showing a favorable bleeding risk profile compared to traditional anticoagulants, making it a suitable option for cancer patients at risk of VTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding. Riaz, IB., Marshall, AL., Badgett, RG.[2020]

In a meta-analysis of 1691 patients undergoing atrial fibrillation ablation, apixaban showed similar rates of thromboembolic events and bleeding complications compared to warfarin, indicating its safety as an anticoagulant in this context.

The study found no deaths and low rates of major and minor bleeding events in patients treated with apixaban, supporting its use as a periprocedural anticoagulation option during AF ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban for periprocedural anticoagulation during catheter ablation of atrial fibrillation: a systematic review and meta-analysis of 1691 patients. Blandino, A., Bianchi, F., Biondi-Zoccai, G., et al.[2018]

Apixaban, an oral direct factor Xa inhibitor, has been approved in the EU for preventing venous thromboembolism (VTE) after hip or knee replacement surgeries, demonstrating its efficacy in reducing the risk of blood clots in these patients.

The drug is also undergoing phase III trials for preventing strokes in patients with atrial fibrillation, indicating its potential for broader applications in thrombotic disorders, although development for acute coronary syndromes has been halted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: first global approval. Watson, J., Whiteside, G., Perry, C.[2021]

Apixaban is an effective oral anticoagulant for treating and preventing venous thromboembolism (VTE), showing noninferiority to the traditional enoxaparin/warfarin treatment in large phase III trials over 6 months.

It has a lower risk of major bleeding compared to enoxaparin/warfarin and is well tolerated, making it a safer alternative for patients with VTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: A Review in Venous Thromboembolism. Greig, SL., Garnock-Jones, KP.[2020]

In the ARISTOTLE trial, apixaban significantly reduced the risk of stroke, systemic embolism, major bleeding, and death compared to warfarin in patients with nonvalvular atrial fibrillation, showing consistent benefits across various patient subgroups.

The AVERROES trial demonstrated that apixaban was more effective than aspirin in preventing stroke or systemic embolism in patients unsuitable for vitamin K antagonist therapy, without increasing the risk of major bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Keating, GM.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Anticoagulation with Factor Xa Inhibitors Is Associated with Improved Overall Response and Progression-Free Survival in Patients with Metastatic Malignant Melanoma Receiving Immune Checkpoint Inhibitors-A Retrospective, Real-World Cohort Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. [2023]

3. England pubmed.ncbi.nlm.nih.gov

LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Apixaban for periprocedural anticoagulation during catheter ablation of atrial fibrillation: a systematic review and meta-analysis of 1691 patients. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Apixaban: first global approval. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of apixaban in the treatment of venous thromboembolism. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Apixaban: A Review in Venous Thromboembolism. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. [2021]