Pharmacokinetics Study Of Rivaroxaban and Apixaban in Can... | NCT05819736

Studies
Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

NCT05819736

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Status

Completed

Last Update Posted

Jun 2, 2026Actual

Enrollment

193Actual

Phase

Not provided

Conditions

Anticoagulants and Thrombotic Disorders

Interventions

Monitoring

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

May 18, 2026Actual

Completion Date

May 18, 2026Actual

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

Apr 6, 2023

First Posted Date

Apr 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joe Elie Salem, Clinical Professor, Clinical Investigation Center Paris Est, Groupe Hospitalier Pitie-SalpetrierePrincipal Investigator

Lead Sponsor

Groupe Hospitalier Pitie-SalpetriereOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

193Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban		Cancer patients treated with rivaroxaban	Other: Monitoring
Apixaban		Cancer patients treated with apixaban	Other: Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monitoring	Other	Monitoring	Apixaban Rivaroxaban

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benoit Blanchet, PharmD, PhD	Assistance Publique - Hôpitaux de Paris	Study Director
Corinne Frere, MD, PhD	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière		Paris		75013	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided