NCT05683808

Brief Summary

This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
12mo left

Started Jan 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2023Jun 2027

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

January 30, 2026

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

January 4, 2023

Last Update Submit

January 27, 2026

Conditions

GlioblastomaAstrocytomaVenous Thromboembolism

Keywords

High grade gliomaGlioblastomaAstrocytomaVenous thromboembolismApixaban

Outcome Measures

Primary Outcomes (1)

  • Safety of apixaban as determined by bleeding risk

    CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.

    6 months

Secondary Outcomes (1)

  • Efficacy in prevention of venous thromboembolism

    6 months

Study Arms (1)

Single arm study

EXPERIMENTAL
Drug: Apixaban

Interventions

ApixabanDRUG

Open label

Single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.
  • Age 18 and old
  • Karnofsky performance status (KPS) 60-100
  • Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.
  • Ability to provide informed consent.
  • Planning for treatment with radiation and chemotherapy.

You may not qualify if:

  • Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.
  • Pregnancy.
  • Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.
  • Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.
  • Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).
  • Estimated life expectancy of \<3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

GlioblastomaAstrocytomaVenous ThromboembolismGlioma

Interventions

apixaban

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Alissa A Thomas, MD

    University of Vermont Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alissa A Thomas, MD

CONTACT

802-847-8400alissa.thomas@med.uvm.edu

Donna Silver

CONTACT

802-656-5040irb@uvm.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Open label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 glioma
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurological Sciences

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

January 16, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

January 30, 2026

Record last verified: 2025-12

Locations

US(1)