Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

Study Overview
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Brief Summary
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Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims : to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.

Detailed Description
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Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims : to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting

Official Title
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Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

Conditions
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Anticoagulants and Thrombotic Disorders

Intervention / Treatment
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* Other: Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects with age ≥ 18 years Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation Patients affiliated with a health insurance system Able to provide written informed consent. Exclusion Criteria: Age <18 years Pregnancy or breastfeeding Patients not affiliated with a health insurance system Patient subject to a measure of protection Legally protected adults Life expectancy < 3 months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban<br>Cancer patients treated with rivaroxaban | Other: Monitoring<br>* Monitoring<br>|
| Apixaban<br>Cancer patients treated with apixaban | Other: Monitoring<br>* Monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population pharmacokinetic evaluation | Estimated area under the curve (AUC) of each of the 2 drugs studied | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation | Any thromboembolic event or major bleeding | 3 years |