Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Completed · Phase 3

Conditions studied: Venous Thromboembolism

In brief

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

Key facts

Study ID

NCT03045406

Run by

Fadoi Foundation, Italy

People needed

1170

Starts

2017-04-13

Expected to finish

2019-12-01

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
• Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia);
• Signed and dated informed consent of the patient, available before the start of any specific trial procedure.

You may not qualify if…

• age <18 years;
• ECOG Performance Status III or IV;
• life expectancy of less than 6 months;
• Related to anticoagulant treatment:
• administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
• 3 or more doses of a vitamin K antagonist before randomization;
• thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
• indication for anticoagulant treatment for a disease other than the index VTE episode;
• Related to bleeding risk:
• thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
• active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
• recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
• hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10\^9/L or history of heparin induced thrombocytopenia;
• creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;
• acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
• uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment);
• concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein;
• Standard criteria:
• bacterial endocarditis;
• hypersensitivity to the active substance or to any of the excipients of study drug;
• patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
• childbearing potential without proper contraceptive measures, pregnancy, or breast feeding;
• any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Brigham and Women's Hospital/DFCI — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• New York-Presbyterian Hospital — New York, New York, United States
• Staten Island University Hospital/Northwell Health — Staten Island, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Cliniques universitaires Saint-Luc — Brussels, Belgium
• KU Leuven — Leuven, Belgium
• Hôpital Privé Arras Les Bonnettes — Arras, France
• CHU Bordeaux Hôpital Saint André — Bordeaux, France
• Hopital Cavale Blanche — Brest, France
• Hôpital des armées HIA Clermont Tonnerre — Brest, France
• Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France
• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.