NCT05732350Completed
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 37 (actual)
- First submitted
- 27 Jan 2023
- Start date
- 11 Nov 2021
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Lung cancer
- NCT number
- NCT05732350
What you commit to
- Study type: Observational
- Participants enrolled: 37
- From 11 Nov 2021 to the primary completion date, 1 Oct 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concurrent medication beside the SMI and DOAC that is known to strongly inhibit or induce CYP3A4 or P-gp
Other
- Unable to understand the information in the patient information letter
- Patients who are pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.