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
Completed
- Conditions
- Solid tumoursthrombo-embolic events10027655
- Registration Number
- NL-OMON52100
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints are DOAC trough and peak concentration before and after<br /><br>start of concomitant use with an SMI (group 1) and DOAC trough and peak<br /><br>concentration during concomitant use with an SMI (group 2). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are percentage of patients with a DOAC concentration within<br /><br>the expected range, percentage of patients with a DOAC concentration outside<br /><br>the expected range, percentage of patients in whom DOAC treatment is modified,<br /><br>SMI trough concentration during steady state and percentage of patients who<br /><br>develop a thromboembolic and/or bleeding event during follow-up. </p><br>