Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

NCT05819736 | Unknown DMC

• 1 other identifier: 2022-10-15
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulants and Thrombotic Disorders

Outcome Measures

Primary Outcomes (1)

• Population pharmacokinetic evaluation

  Estimated area under the curve (AUC) of each of the 2 drugs studied

  3 years

Secondary Outcomes (1)

• Safety evaluation

  3 years

Study Arms (2)

Rivaroxaban

Cancer patients treated with rivaroxaban

Other: Monitoring

Apixaban

Cancer patients treated with apixaban

Other: Monitoring

Interventions

Monitoring OTHER

Monitoring

Apixaban; Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with atrial fibrillation or venous thromboembolism receiving rivaroxaban or apixaban in a real-life clinical setting

You may qualify if:

• Male or female subjects with age ≥ 18 years
• Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation
• Patients affiliated with a health insurance system
• Able to provide written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Benoit Blanchet, PharmD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Corinne Frere, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Benoit Blanchet, PharmD, PhD

CONTACT

158412889; benoit.blanchet@aphp.fr

Corinne Frere, MD, PhD

CONTACT

142162458; corinne.frere@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Clinical Investigation Center Paris Est

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (1)