Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

Recruiting

• Conditions: Anticoagulants and Thrombotic Disorders
• Interventions: Other: Monitoring

• Registration Number: NCT05819736
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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

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

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Monitoring	Cancer patients treated with rivaroxaban
Apixaban	Monitoring	Cancer patients treated with apixaban

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetic evaluation	3 years	Estimated area under the curve (AUC) of each of the 2 drugs studied

Secondary Outcome Measures

Name	Time	Method
Safety evaluation	3 years	Any thromboembolic event or major bleeding

Trial Locations

Locations (1)

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France