Solid TumorNCT05732350
Exploratory Drug Interaction Study Between SMIs and DOACs
An observational study of Solid Tumor and Cancer, Lung, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Cancer, Lung
- How many people
- 37 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Nov 2021to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer who will be, or are already, treated with an SMI and a DOAC simultaneously, at the MUMC+ or Radboudumc can participate in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht UMC
Maastricht, Limburg, 6202AZ
Radboud UMC
Nijmegen, Gelderland, 6500HB
About this study
Official title: 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
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).
Read the detailed description
Patients who receive anticoagulant therapy in the form of a direct oral anticoagulant (DOAC) and simultaneously receive anti-cancer targeted therapy with a small molecule inhibitor (SMI), potentially have an increased risk on thromboembolic complications and bleeding events due to interfering drug-drug interactions. Some SMIs influence CYP3A4 and/or p-glycoprotein (p-gp) for which DOACs are substrates. In this study, the effect of theoretically relevant SMIs on the pharmacokinetics, efficacy and safety of DOACs in patients with solid tumours will be investigated. For this purpose, plasma concentration analyses will be performed.
- Conditions
- Solid Tumor, Cancer, Lung
- Keywords
- direct oral anticoagulant, targeted therapy, small molecule inhibitors, Therapeutic drug monitoring
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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. | |
| Group 2 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOAC trough concentration
DOAC trough concentration before and during concomitant use with an SMI
Measured: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
DOAC peak concentration
DOAC peak concentration before and during concomitant use with an SMI
Measured: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
Secondary outcomes (2)
Thromboembolic and bleeding events during follow-up
Thromboembolic and bleeding events during follow-up
Measured: within 6 months after the last blood sampling
SMI trough concentration during concomitant use with a DOAC
SMI steady-state trough concentration during concomintant use with a DOAC
Measured: After the start of the DOAC use in combination with an SMI at steady-state (after at least 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start11 Nov 2021
- Primary completion1 Oct 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Robin van Geel, PharMD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732350
- Sponsor's protocol ID
- NL78003.068.21
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05732350
- Acronym / sponsor ID
- NL78003.068.21
- Conditions
- Solid Tumor, Cancer, Lung
- Keywords
- direct oral anticoagulant, targeted therapy, small molecule inhibitors, Therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients who receive anticoagulant therapy in the form of a direct oral anticoagulant (DOAC) and simultaneously receive anti-cancer targeted therapy with a small molecule inhibitor (SMI), potentially have an increased risk on thromboembolic complications and bleeding events due to interfering drug-drug interactions. Some SMIs influence CYP3A4 and/or p-glycoprotein (p-gp) for which DOACs are substrates. In this study, the effect of theoretically relevant SMIs on the pharmacokinetics, efficacy and safety of DOACs in patients with solid tumours will be investigated. For this purpose, plasma concentration analyses will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –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. |
| Group 2 | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer who will be, or are already, treated with an SMI and a DOAC simultaneously, at the MUMC+ or Radboudumc can participate in this study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DOAC trough concentration
Time frame: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
DOAC trough concentration before and during concomitant use with an SMI
DOAC peak concentration
Time frame: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
DOAC peak concentration before and during concomitant use with an SMI
2 secondary outcomes
Thromboembolic and bleeding events during follow-up
Time frame: within 6 months after the last blood sampling
SMI trough concentration during concomitant use with a DOAC
Time frame: After the start of the DOAC use in combination with an SMI at steady-state (after at least 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin van Geel, PharMD, PhD principal investigator
Maastricht UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Cancer, Lung, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOAC trough concentration (time frame: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.