New dose strategy aims to cut bleeding in cancer patients on blood thinners
NCT ID NCT06886516
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a specially adjusted dose of the blood thinner apixaban can safely treat blood clots in cancer patients who also have low platelet counts. About 30 adults with active cancer and a recent clot will receive the adjusted dose. The goal is to see if this approach reduces bleeding while still preventing new clots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months. * Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated thrombosis will be included, as will distal lower extremity DVTs. * Platelet count \< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis. * Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3 transfusions. * No evidence of active hemorrhage. * No recent history of major hemorrhage (requiring transfusion, hospitalization or intervention) within the last 12 months. * No known brain metastases. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of apixaban in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. * ECOG performance status ≤2 * Participants must have adequate organ and marrow function as defined below: * Total bilirubin ≤ institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Glomerular filtration rate (GFR) ≥25 mL/min/1.73/m2 * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * The effects of apixaban on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of apixaban administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who are receiving any other investigational agents. * Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent. * Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or pulmonary embolism with hemodynamic compromise. * Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant. * Participants with luminal gastrointestinal malignancy or genitourinary cancer. * Presence of known or prior brain metastasis, given the increased risk of life-threatening intracranial hemorrhage with anticoagulant use. While screening for brain metastases is not standard of care in this population, investigators may obtain brain imaging if clinically indicated prior to initiation of anticoagulation. Imaging is not mandated in order to participate in this study. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban. * Participants receiving any medications or substances that are inhibitors or inducers of CYP3A/P-gp are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. * Participants on aspirin (\>100 mg/day), dual antiplatelet therapy, or receiving chronic treatment with NSAIDS * Participants with uncontrolled intercurrent illness. * Participants at high risk of bleeding such as: * Unresected luminal/mucosal GI and GU cancers * Active gastric or duodenal cancer * History of major bleeding (based on ISTH criteria) in the past 12 months * Any prior history of Intracranial hemorrhage (microhemorrhage is not included) * Clinical or laboratory concern for ongoing DIC (prolonged PT/APTT or low fibrinogen) * Severe renal disease (CKD Stage IV or higher) or liver disease (Child Pugh B/C) * Participants with pre-planned major surgery within the study period * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because apixaban has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with apixaban, breastfeeding should be discontinued if the mother is treated with apixaban. * Participant must be able to swallow pills.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Other studies related to the condition(s) this trial covers.
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