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Apixaban for the Treatment of Venous Thromboembolism in Patients with Cancer: A Prospective Randomized Open Blinded End-Point (PROBE) Study - The Caravaggio Study

Clinical Trial Details

This research study is a Phase IIIb clinical trial. Phase IIIb clinical trials examine the safety and effectiveness of a drug or treatment, often comparing it to another known treatment. 

Subjects with cancer who developed venous thromboembolism (VTE) are generally treated with an anticoagulation drug. Anticoagulation drugs, which are also called blood thinners, help prevent the blood from clotting in your blood vessels. 

Venous Thromboembolism is a disease combined of two serious conditions: 

  • Deep Vein Thrombosis (DVT) - a blood clot that is present in a deep vein in your body, usually in the lower leg, the thigh, or in the pelvis and can block partially or totally the flow of blood in your body 
  • Pulmonary Embolism (PE) - a blood clot that is blocking one or more blood vessels in the lungs     

In this research study, we are looking to see whether apixaban (Eliquis®) works as well as dalteparin, which is the standard treatment for cancer patients with VTE. The comparison between the two drugs will done by a study design known as non-inferiority to measure efficacy (desired action) and safety. 

Both dalteparin and apixaban are anticoagulation drugs. Apixaban and dalteparin are both approved in Europe and in the United States to treat patients with VTE, but only dalteparin is approved to treat VTE in patients with cancer. 

Subjects with cancer who have a DVT or PE are generally treated with a blood thinner, such as dalteparin. The aim of this study is to compare apixaban, which is taken by mouth, with dalteparin (a low molecular weight heparin drug [LMWH]), which is given as a shot, for the treatment of DVT and PE in patients. 

Apixaban is an oral drug that can be taken twice a day as a pill and is approved by the FDA to treat VTE in people without cancer. Apixaban was tested in several clinical trials for management of VTE and was proved to be an effective anticoagulant. There were a low number of patients with cancer in these trials. In some of the trials, participants who have cancer associated VTE did do as well with apixaban as with the standard treatment warfarin. This current study is designed for cancer patients only. Apixaban was developed by Bristol-Myers Squibb (BMS) and Pfizer and has been already approved for use in Europe and in the United States. 

Dalteparin is the standard treatment approved by the FDA for managing VTE in patients with cancer, and it is a drug that is injected under the skin (sub-cutaneous injection). Dalteparin is approved by FDA for the treatment of DVT and PE in patients with and without cancer. If you agree to participate, you will be assigned to either the dalteparin or apixaban treatment group by a computer decision making system that randomly selects which drug you will be treated with. There is a 50% chance that you will receive apixaban and a 50% chance that you will receive dalteparin. 

Key Eligibility: 

Inclusion Criteria

  • 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 known intracerebral metastases and acute leukemia)

Exclusion Criteria         

  • Less than 18 years old 
  • Life expectancy of less than 6 months 
  • Concomitant thienopyridine therapy or aspirin over 165 mg daily or dual antiplatelet therapy 
  • Active bleeding or high risk of bleeding
  • Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery 
  • Acute hepatitis, chronic active hepatitis, or liver cirrhosis
  • Uncontrolled hypertension
  • Bacterial endocarditis 
  • Women of childbearing potential (WOCBP) who do not practice a medically accepted highly effective contraception during the trial and one month beyond

Study contact by location

Upper East Side - Manhattan

Contact(s)

Elizabeth Newman
(646) 962-2065
eln9011@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1808019521

Sponsor:

FADOI 03.2016

Status

Open to Enrollment

Age Group

Adult

Sponsor