Apixaban for Preventing Blood Clots in Cancer Patients

Recruiting at 32 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Academic and Community Cancer Research United

No Placebo Group All 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 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: 52 weeks

370 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like strong CYP3A4 inducers or inhibitors, or thienopyridine therapy, unless you can switch to a different medication or stop them. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Apixaban for preventing blood clots in cancer patients?

Research shows that Apixaban is effective in reducing the rate of blood clots in cancer patients, similar to other treatments like Rivaroxaban, without increasing major bleeding. It has also been shown to significantly decrease blood clots in patients starting chemotherapy compared to a placebo. ^{1 2 3 4 5}

Is Apixaban safe for cancer patients?

Apixaban has been studied for safety in cancer patients, showing that it can be used to prevent blood clots, but there is a risk of bleeding. It has been approved for preventing blood clots after surgeries like hip or knee replacement, and safety measures include educational materials to minimize bleeding risks. ^{3 4 6 7 8}

How does the drug apixaban differ from other treatments for preventing blood clots in cancer patients?

Apixaban is unique because it is an oral medication that directly inhibits factor Xa, a key protein in the blood clotting process, and does not require routine blood monitoring like some other anticoagulants. It has been shown to significantly reduce the risk of blood clots in cancer patients undergoing chemotherapy, offering a convenient and effective alternative to traditional treatments like warfarin, which often require more frequent monitoring and dose adjustments. ^{4 6 7 9 10}

Research Team

Robert D McBane

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

This trial is for cancer patients who've finished at least 6 months of blood clot treatment, have a life expectancy of over 6 months, and are in fairly good health. They must not be pregnant or nursing, agree to use contraception if necessary, and cannot have severe liver disease or recent bleeding issues.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is adequate.

Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study. If you have had your period and are not in menopause or sterilized, you are considered able to become pregnant.

I have active cancer, confirmed by scans or treatment in the last 6 months.

Exclusion Criteria

Pregnant women

You have had a serious allergic reaction to apixaban.

You had bleeding inside your eye within the last 6 months before the study starts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a lower or higher dose of apixaban orally twice daily for 365 days

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Apixaban

Trial Overview The study tests how well Apixaban works in preventing new blood clots after previous clot treatment in cancer patients. It's a phase III trial where the effectiveness and optimal dose of Apixaban will be determined by comparing it with other treatments.

Participant Groups

Group I: Group II (higher dose apixaban) Experimental Treatment 1 Intervention

Patients receive higher dose apixaban PO BID for 365 days.

Group II: Group I (lower dose apixaban) Experimental Treatment 1 Intervention

Patients receive lower dose apixaban PO BID for 365 days.

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 2,437 patients with cancer-associated venous thromboembolism (VTE), rivaroxaban and apixaban demonstrated similar effectiveness and safety profiles, with no significant differences in the risk of recurrent VTE or hospitalization due to bleeding over a 6-month period.

Both anticoagulants showed comparable outcomes, suggesting that clinicians can choose between rivaroxaban and apixaban based on patient preference and adherence, rather than differences in efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding. Caroti, KS., Becattini, C., Carrier, M., et al.[2023]

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]

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]

Healthcare professionals (HCPs) and patients demonstrated satisfactory knowledge of bleeding risks associated with apixaban, with 96.1% of HCPs recognizing symptoms that require immediate attention and 71.2% of patients identifying abnormal bleeding as a significant side effect.

The study found that a significant majority of HCPs (97.8%) who received the Prescriber Guide utilized it in patient discussions, and 90.9% of patients who received the Patient Alert Card read it at least once, indicating effective distribution and utilization of these educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of apixaban in the treatment of venous thromboembolism. Koehl, JL., Hayes, BD., Al-Samkari, H., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding. [2023]

2. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

Risk Factors for Bleeding in Cancer Patients Treated with Conventional Dose Followed by Low-Dose Apixaban for Venous Thromboembolism. [2023]

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

Efficacy of primary prevention of venous thromboembolism among subgroups of cancer patients undergoing chemotherapy: A post- hoc analysis of the AVERT trial. [2021]

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

Arterial events in cancer patients treated with apixaban for venous thrombosis. [2023]

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

Efficacy and Safety of Apixaban Versus Warfarin in Patients with Atrial Fibrillation and a History of Cancer: Insights from the ARISTOTLE Trial. [2022]

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

Apixaban: first global approval. [2021]

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

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Apixaban: A Review in Venous Thromboembolism. [2020]