Apixaban for Preventing Blood Clots in Cancer Patients

Recruiting in Palo Alto (17 mi)

+32 other locations

Overseen byRobert D McBane

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

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.

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.

+8 more

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.

+17 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Group II (higher dose apixaban)Experimental Treatment1 Intervention

Patients receive higher dose apixaban PO BID for 365 days.

Group II: Group I (lower dose apixaban)Experimental Treatment1 Intervention

Patients receive lower dose apixaban PO BID for 365 days.