Abelacimab vs Apixaban for Cancer-Related Blood Clots

(ASTER Trial)

Not currently recruiting at 240 trial locations
NW
DF
JM
Overseen ByJohn McRae
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Anthos Therapeutics, Inc.
Must be taking: DOACs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments, abelacimab (an experimental treatment) and apixaban, to determine which is more effective at preventing the recurrence of blood clots and reducing bleeding in people with cancer. Blood clots, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), often affect those with cancer. Participants must have an active cancer diagnosis and have recently experienced a blood clot in a major vein or lung artery. The trial seeks to identify the most effective and safe treatment option for managing these clots in cancer patients. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, abelacimab has been shown to be safe for patients with cancer-related blood clots. Research suggests it could be a good option for long-term treatment because most people tolerate it well. One study found that the main safety concern was bleeding, though this was uncommon. The treatment remains under study, so more information is needed to fully understand its safety.

Apixaban, however, is already approved and commonly used for treating blood clots, with well-known safety. Most people tolerate it well, but like many blood thinners, it can increase the risk of bleeding.

Both treatments aim to prevent blood clots, but their safety profiles might differ. Considering these differences is important when deciding to join a trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard of care for cancer-related blood clots, which typically involves oral anticoagulants like Apixaban, Abelacimab offers a unique approach with its novel mechanism. Abelacimab targets factor XI, a key player in blood clot formation, and is administered initially through an intravenous dose followed by monthly subcutaneous injections. This method could potentially improve patient compliance and reduce the risk of bleeding, a common complication with current options. Researchers are excited about Abelacimab because it promises a new way to manage clotting with potentially fewer side effects and more convenient dosing.

What evidence suggests that this trial's treatments could be effective for cancer-related blood clots?

Research shows that abelacimab, one of the treatments tested in this trial, is a promising blood thinner for treating blood clots in cancer patients. Earlier studies have shown its potential to prevent strokes with a low risk of causing bleeding. Abelacimab targets a specific part of the blood clotting process, which might offer advantages over traditional treatments. In contrast, apixaban, the other treatment option in this trial, is already a well-known treatment for blood clots and has proven effective in reducing the risk of clots in cancer patients. This study compares both treatments to determine which one better prevents clots from returning and causes less bleeding.12367

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Abelacimab
  • Apixaban
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: AbelacimabExperimental Treatment1 Intervention
Group II: ApixabanActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anthos Therapeutics, Inc.

Lead Sponsor

Trials
6
Recruited
6,600+

Itreas

Collaborator

Trials
2
Recruited
2,700+

Published Research Related to This Trial

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.
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 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.
Apixaban: A Review in Venous Thromboembolism.Greig, SL., Garnock-Jones, KP.[2020]
Apixaban is an effective direct oral anticoagulant for treating venous thromboembolism (VTE), showing safety and efficacy in large phase III trials, making it a convenient alternative to warfarin.
However, there is limited research on its use in certain populations, such as patients over 75, those with cancer, and pediatric patients, indicating a need for further studies in these groups.
A comprehensive evaluation of apixaban in the treatment of venous thromboembolism.Koehl, JL., Hayes, BD., Al-Samkari, H., et al.[2021]

Citations

NCT05171049 | A Study Comparing Abelacimab to ...A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE (ASTER). ClinicalTrials.gov ID NCT05171049. Sponsor Anthos ...
Abelacimab in Cancer-Associated Thrombosis: The Right ...Abelacimab is a new and attractive anticoagulant for the management of CAT, especially in the insidious and critical scenario of active cancer patients.
Anthos Therapeutics Launches Second Phase 3 Clinical ...The MAGNOLIA study will compare abelacimab against the current standard of care for VTE in cancer associated thrombosis (CAT) in patients with GI/GU cancers.
A Study Comparing Abelacimab to Apixaban in the ...This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous ...
Abelacimab: the next frontier in safer anticoagulation therapyAbelacimab represents a breakthrough in drug discovery, offering a novel approach to anticoagulation that could potentially prevent strokes with minimal ...
Abelacimab for Prevention of Venous ThromboembolismThe principal safety outcome was a composite of major or clinically relevant nonmajor bleeding up to 30 days after surgery. Results. Venous ...
A leap forward in anticoagulation with FXI and FXIa InhibitionWhile awaiting FDA approval, abelacimab stands out as a promising anticoagulant agent. Nonetheless, more data may be needed to establish its efficacy and safety ...
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