Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study

Study Overview
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Brief Summary
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This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in patients with cancer. The current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. During the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. But very few cancer patients were included in the phase III clinical trials of the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. The current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.

Official Title
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Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study

Conditions
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Neoplasms, Venous Thrombosis

Intervention / Treatment
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* Drug: Apixaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer. Objectively verified venous thrombosis Informed consent Exclusion Criteria: Anticoagulant therapy prior to trial entry for > 96 hours Severe thrombocytopenia (platelets <50·109/L) Severe renal failure - creatinine clearance <30 ml/min The patients will be treated with catheter based thrombolysis for deep venous thrombosis or systemic thrombolysis for severe pulmonary embolism Pregnancy or breastfeeding. Childbearing potential without proper contraceptive measures Drug abuse or mental disease that may interfere with treatment and follow-up. Severe malabsorption so that oral treatment are expected to have reduced effect Mechanical heart valves Known allergy to apixaban Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the venous thrombosis Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis) Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, voriconazole or posaconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apixaban<br>Apixaban 10 mg two times daily for 1 week, then apixaban 5mg two times daily for 6 months, then apixaban 2.5 mg two times daily for as long as the treating physician finds it necessary. | Drug: Apixaban<br> <br> * Other names: Eliquis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis |  | 6 months after inclusion | 
| Major or clinically relevant non-major bleeding |  | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 6 months after inclusion | 
| All cause mortality |  | 24 months after inclusion | 
| Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis |  | 24 months after inclusion | 
| Major or clinically relevant non-major bleeding |  | 24 months after inclusion |