Real-world exploratory evaluation of the potential drug-drug interaction between anticancer small molecule inhibitors and direct oral anticoagulants in patients with solid tumours, and exploration of the role of therapeutic drug monitoring

Real-world exploratory evaluation of the potential drug-drug interaction between anticancer small molecule inhibitors and direct oral anticoagulants in patients with solid tumours, and exploration of the role of therapeutic drug monitoring - Exploratory drug interaction study between SMIs and DOACs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52100

Enrollment

Registered

2021-10-11

Start date

2021-12-22

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumours thrombo-embolic events

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Treatment of a solid tumour with a SMI 18 years of age or older Already receive or start treatment with a SMI-DOAC combination that may cause a potential clinically significant DDI at the level of CYP3A4 and/or P-gp Combined use of a DOAC-SMI combination is expected to be continued at the same dose for at least three weeks from start of the combined intake DOAC is used for at least 7 days and SMI for at least 21 days before the first blood sampling

Exclusion criteria

Exclusion criteria: Any concurrent medication besides the SMI and DOAC that is known to strongly inhibit or induce CYP3A4 or P-gp Patients who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
The primary endpoints are DOAC trough and peak concentration before and after start of concomitant use with an SMI (group 1) and DOAC trough and peak concentration during concomitant use with an SMI (group 2).	—

Secondary

Measure	Time frame
Secondary endpoints are percentage of patients with a DOAC concentration within the expected range, percentage of patients with a DOAC concentration outside the expected range, percentage of patients in whom DOAC treatment is modified, SMI trough concentration during steady state and percentage of patients who develop a thromboembolic and/or bleeding event during follow-up.	—

Countries

Netherlands

Outcome results