Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT05732350
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05732350
Study Brief:
Protocol Section:
NCT05732350