Clinical trial · Observational
Exploratory Drug Interaction Study Between SMIs and DOACs
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
NCT05732350CI-TRIAL-00074708completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to investigate the effect of small molecule inhibitors (SMIs), used in targeted therapy for tumours, on direct oral anticoagulants (DOACs).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Patients in group 1 already receive a DOAC and will start treatement with an SMI. Blood samples will be drawn before start of the SMI and during concomittant use with the SMI.
- label
- Group 2
- description
- Patients in group 2 already use a potentially relevant DOAC-SMI combination or already use an SMI and start with a DOAC. In this group, blood samples are taken after the start of concomittant use of the DOAC-SMI combination.
Primary outcomes (2)
- measure
- DOAC trough concentration
- timeFrame
- At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
- description
- DOAC trough concentration before and during concomitant use with an SMI
- measure
- DOAC peak concentration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with a solid tumour * 18 years of age or older * Patients receive or start treatment with an SMI-DOAC combination, that may cause a clinically significant DDI at the level of CYP3A4 and/or P-gp, based on the SmPC * Combined use of a DOAC-SMI combination is expected to be continued at the same dose for at least three weeks * The DOAC is used for at least seven days and the SMI has already been used for at least 21 days at time of blood collection to ensure steady-state * Patients receive a DOAC at maintenance dose Exclusion Criteria: * Unable to understand the information in the patient information letter * Any concurrent medication beside the SMI and DOAC that is known to strongly inhibit or induce CYP3A4 or P-gp * Patients who are pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.