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Deep Vein ThrombosisEarly Phase 1NCT06886516

Apixaban in Thrombocytopenia

A Early Phase 1 study testing Apixaban in people with Deep Vein Thrombosis and Pulmonary Embolism and Thrombosis, run by Rushad Patell at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apixaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
28 Feb 2025to 1 Jul 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rushad Patell, MD contact

617-667-9179

rpatell@bidmc.harvard.edu

Fernanda De Queiroz Silva, MD contact

617-667-9920

fdequeir@bidmc.harvard.edu

United States1 site, 1 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Rushad Patell, MD, 617-667-9179, rpatell@bidmc.harvard.edu

    Rushad Patell, MD

    Recruiting

Other trials in United States

About this study

Official title: ADAPTiON: Apixaban Dose Adjustment in Patient With Thrombocytopenia in ONcology

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.

The name of the study drug involved in this study is:

-Apixiban (a type of anticoagulant)

Read the detailed description

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood).

This study is a feasibility study, which is the first-time investigators are examining this drug, Apixaban, for cancer-associate VTE or thrombocytopenia. Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.

The U.S. Food and Drug Administration (FDA) has approved apixaban as a treatment option for venous thromboembolism (VTE) and stroke prevention in patients with atrial fibrillation (irregular and fast heartbeat). This study is investigating apixaban taken by mouth (with adjusted doses) as a treatment for VTE in participants with active malignancies (cancer) and thrombocytopenia which has not been studied or FDA approved.

The research study procedures include screening for eligibility, in-clinic visits, and blood tests.

Participants will receive study treatment for 90 days and will be followed for 6 weeks after stopping study treatment.

It is expected that about 30 people will take part in this research study.

Being tested
Apixaban
Keywords
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Thrombocytopenia, Thromboembolism, Recurrent Venous Thromboembolism
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Thrombosis, Thrombocytopenia, Venous Thromboembolism, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called 1-(4methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4c]pyridine-3-carboxamide, C25H25N5O4

    A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.

Study groups in NCT06886516
Study groupRoleWhat they receive
DOSE-ADJUSTED APIXABANExperimental30 enrolled participants will complete study procedures as follows: * Baseline visit with assessments * Predetermined dose of Apixiban 2x daily for 90 days * Off treatment visit 7 days after last study drug dose * Follow up visit 6 weeks after last study drug dose
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Enrollment

    Study enrollment is defined as documentation of informed consent for participants approached.

    Measured: Up to 5 years

Secondary outcomes (7)

  1. Rate of Enrolled Participants With Administration of at Least 1 Dose of Apixaban

    Feasibility is achieved if 75% of participants received at least 1 dose of apixaban.

    Measured: Up to 3 months

  2. Study Drug Adherence Rate

    Study drug adherence is defined as the proportion of participants that take over 80% of prescribed doses based on pill count. Success is defined as 75% or above.

    Measured: Up to 3 months

  3. Platelet Count Monitoring Plan Adherence Rate

    Platelet Count Monitoring Plan Adherence Rate is defined as proportion of participants that receive at least 80% of platelet counts within frequency stipulated by the study protocol. Success is defined as 75% or above.

    Measured: Up to 3 months

  4. Study Completion Rate

    Study is completed when participants finish the 90-day period or terminate due to event that qualifies as an outcome.

    Measured: Up to 3 months

  5. Major Bleeding Rate

    Major bleeding rate is defined as the proportion of participants who experience major bleeding during the study.

    Measured: Up to 3 months

  6. Clinically Relevant Non-Major Bleeding Rate

    Clinically relevant major bleeding rate is defined as the proportion of participants who experience a clinically relevant non-major bleeding event.

    Measured: Up to 3 months

  7. Recurrent Venous Thromboembolism Rate (VTE)

    Recurrent VTE rate is defined as the proportion of participants who experience recurrent VTE, including pulmonary embolism and lower extremity deep vein thrombosis.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start28 Feb 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886516
Sponsor's protocol ID
24-110
Status last verified
Apr 2026
First submitted
14 Mar 2025
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Apixaban in people with Deep Vein Thrombosis and Pulmonary Embolism and Thrombosis, run by Rushad Patell at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rushad Patell, MD (617-667-9179, rpatell@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Enrollment (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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