Apixaban for Brain Tumor

(VTE-POG Trial)

Overseen By Donna Silver

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Vermont Medical Center

Must not be taking: Heparin, Dabigatran, Rivaroxaban, others

Disqualifiers: Pregnancy, Bleeding risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if apixaban, a type of blood thinner, can prevent blood clots in individuals with newly diagnosed grade 4 brain tumors, such as glioblastoma. The research seeks to establish whether apixaban can be safely used alongside radiation and chemotherapy. Suitable participants have recently undergone a biopsy or surgery confirming a grade 4 brain tumor and are planning to receive radiation and chemotherapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are currently taking certain blood thinners like heparin or other similar medications, you will need to stop them to participate in this trial. The trial does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that apixaban is likely to be safe for humans?

Research has shown that apixaban is generally safe for patients with certain types of cancer. In a large study involving over 30,000 cancer patients, including 5% with brain cancer, apixaban proved safer than other blood thinners like warfarin and LMWH, with a lower risk of causing serious bleeding. Another study found that using apixaban in patients with brain tumors did not increase the risk of major bleeding compared to other treatments.

However, some studies did not include patients with brain tumors. This means that while apixaban is well-tolerated in many cases, there is less information specifically for those with brain cancer. Overall, apixaban appears to be one of the safer blood thinners for cancer patients, but more research is needed for those with brain tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain tumors?

Unlike the standard treatments for brain tumors, which often involve surgery, radiation, or chemotherapy, Apixaban is an anticoagulant that's being explored for its potential to reduce blood clots associated with tumors. Researchers are excited about Apixaban because it offers a novel approach by targeting the clotting pathway, which might help manage complications without the need for more invasive procedures. Additionally, by addressing clotting, Apixaban could potentially improve the quality of life for patients by reducing the risk of stroke or other clot-related issues common in those with brain tumors.

What evidence suggests that apixaban might be an effective treatment for venous thromboembolism prevention in grade 4 glioma patients?

Research has shown that apixaban, the investigational treatment in this trial, effectively prevents blood clots, known as venous thromboembolism (VTE), in cancer patients. Studies have found that apixaban carries a lower risk of causing repeat blood clots and major bleeding compared to treatments like low-molecular-weight heparin and warfarin. Specifically, for patients with brain tumors, apixaban was associated with a significantly lower risk of bleeding in the brain than some other blood thinners. These findings suggest that apixaban may be a safer choice for preventing blood clots in patients with brain cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Alissa A Thomas, MD

Principal Investigator

University of Vermont Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with a recent diagnosis of grade 4 malignant glioma, including glioblastoma and astrocytoma. Participants must be over 18, have a Karnofsky performance status between 60-100, acceptable lab results (platelets ≥100,000; GFR ≥25), and plan to undergo radiation and chemotherapy.

Inclusion Criteria

My diagnosis is a grade 4 brain tumor, such as glioblastoma.

I am 18 years old or older.

I can care for myself but may not be able to do active work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apixaban for the prevention of venous thromboembolism

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban

Trial Overview

The study is testing Apixaban as an open-label intervention to prevent venous thromboembolism in patients with newly diagnosed grade 4 gliomas who are undergoing standard treatment.

How Is the Trial Designed?

Group I: Single arm study Experimental Treatment 1 Intervention

Apixaban is already approved in European Union, United States for the following indications:

Approved in European Union as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation

Approved in United States as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9939345/

DOACs for VTE in patients with brain cancer and ... - PMC - NIH

Dabigatran is associated with the best risk reduction of ICH compared with warfarin (warfarin, 60%; apixaban, 57%; edoxaban, 56%; rivaroxaban, 41%).

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0049384823001019

Effectiveness and safety of anticoagulants among venous ...

Of 30,586 patients with active cancer (5 % had brain cancer), apixaban (vs. LMWH and warfarin) was associated with lower risk of rVTE, MB, and CRNMB. Generally, ...

3.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000214140

Intracranial Hemorrhage With Direct Oral Anticoagulants vs ...

Patients with primary or metastatic brain tumors receiving DOACs had a statistically significantly lower risk of any ICH compared with LMWH (RR ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1915103

Apixaban for the Treatment of Venous Thromboembolism ...

Our trial investigated the efficacy and safety of apixaban during the initial 6-month treatment of venous thromboembolism in patients with cancer.

5.

jthjournal.org

jthjournal.org/article/S1538-7836(23)00779-1/fulltext

Comparison of direct oral anticoagulants versus low- ...

To conduct a meta-analysis and systematic review of studies that compare the risk of intracranial hemorrhage (ICH) in patients with brain cancer treated with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8100560/

Safety of Direct Oral Anticoagulants in Central Nervous ... - PMC

Our conclusion is that DOAC use in patients with brain tumors is not associated with increased rates of major bleeding compared with LMWH and is a safe and ...