Drug Drug Interaction StudyPhase 4ROSIENCT06314763
Rivaroxaban Sotorasib Interaction Study
A Phase 4 study testing Rivaroxaban 20mg and Sotorasib 960mg in people with Drug Drug Interaction Study, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of >15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction Study
- What is being tested?
- Rivaroxaban 20mg and Sotorasib 960mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Nov 2023to 21 Mar 2024
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 18 and not older than 65 years at screening.
- Subject does not smoke more than 10 (e-)cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first study day.
- Subject has a Body Mass Index of 18 to 30 kg/m2 .
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is in good age-appropriate health condition as established by medical history and physical examination within 4 weeks prior to day 1.
- Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Who cannot join
- An estimated glomerular filtration or creatinine clearance of less than 70mL/min.
- Liver enzyme tests (ALAT, ASAT, GGT, total bilirubin, ALP) greater than 2 times the upper limit of normal.
- Serum electrolytes (sodium, potassium, calcium, magnesium) outside the normal range of the NVKC reference ranges.
- Hemocytometric values (hemoglobin, hematocrit, leukocytes, erythrocytes and thrombocytes) outside of the NVKC reference ranges.
- A prothrombin time (PT) > 13.3 seconds.
- An activated partial thromboplastin time (APTT) >38 seconds.
Show all 30Show fewer
- Clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood.
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Female subject is pregnant or lactating/breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib.
- Female subjects of childbearing potential unwilling to use an effective method of contraception during treatment and for an additional 7 days after the last dose of sotorasib.
- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib.
- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of sotorasib.
- Consumption of foods and beverages containing poppy seeds, St. Johns Wort, grapefruit, or Seville oranges within 7 days prior to check-in.
- Concomitant use of drugs, including herbs and food additives, with a pharmacokinetic or pharmacodynamic interaction, as assessed with most recent KNMP kennisbank and uptodate.com drug interaction databases.
- Donation of plasma or blood (450ml or more) less than 2 months before start of the study.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- History of or current abuse of drugs or alcohol.
- Inability to understand the nature and extent of the study and the procedures required.
- Febrile illness within 3 days before Day 1.
- History of internal bleeding of any genesis.
- Known present congenital or acquired bleeding disorders.
- History of liver disease.
- History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- Known gastrointestinal disease without active ulceration that can potentially lead to bleeding complications.
- History of vascular retinopathy.
- Known bronchiectasis.
- History of pulmonary bleeding.
- The following conditions known in medical history: coronary heart disease, previous cerebrovascular accident (CVA) or transient ischaemic attack.
- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis B). Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody [anti-HBs] testing is necessary. Undetectable anti-HBs in this setting would suggest unclear and possible infection and needs exclusion).
- Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction (PCR) is necessary. Detectable Hepatitis C virus RNA suggests chronic hepatitis C.
Trial locations and contacts
1 site in 1 country.
About this study
Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of >15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US [FDA] and EU [EMA] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs.
Read the detailed description
Objective:
To assess the pharmacokinetics of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state
Main study parameters/endpoints:
The geometric mean ratios of area under the concentration time curve (AUC) and maximum concentration (Cmax) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals.
Study design:
An open label single-sequence pharmacokinetic drug-drug interaction study in healthy volunteers.
Study population:
Healthy human volunteers aged between 18 and 65. Volunteers can't participate in this study if they have an increased risk for bleeding or blood clotting. Furthermore, volunteers receiving concomitant drugs with a pharmacokinetic or pharmacodynamic interaction with the investigational medicinal products will also be excluded.
Intervention:
The pharmacokinetics of a single dose rivaroxaban are assessed in presence and absence of sotorasib. The study participants will receive rivaroxaban (20 mg single dose ingested with food) on day 1, followed by a wash-out period on day 1 and 2, followed by daily administration of sotorasib 960 mg once daily on day 3-16 and rivaroxaban (20 mg single dose ingested with food) on day 16.
The pharmacokinetics of rivaroxaban will be assessed at T=0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration on the days that rivaroxaban is administered.
The pharmacokinetics of sotorasib will be assessed at T=0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24h after administration on day 16.
Ethical consideration to the clinical trial including the expected benefit to the individual subject or group of patients represented by the study participants as well as the nature and extent of burden and risks: A drug-drug interaction study in patients on sotorasib is not considered feasible and methodologically sound, due to high co-morbidity and polypharmacy in patients with an indication for treatment with sotorasib. Single dose pharmacokinetic rivaroxaban studies in healthy volunteers are common and the gold standard to assess the impact of drug-drug interactions with DOACs. Single and multiple dose studies of sotorasib in healthy volunteers are considered and proven safe, likely due to high selectivity of the drug for KRAS G12C mutation that is only present in tumor cells of individuals with KRAS G12C mutated cancer. There is no individual benefit for participation in the study.
- Conditions
- Drug Drug Interaction Study
- Being tested
- Rivaroxaban 20mg, Sotorasib 960mg
- Keywords
- Lung cancer, Non small cell lung cancer, NSCLC, Sotorasib, Lumykras, Lumakras, Rivaroxaban, Xarelto, DOAC, Enzyme inhibitors, Molecular Mechanisms of Pharmacological Action, Venous thromboembolism
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20mgDrug
Also called Xarelto
Single dose on day 1 and day 16
Sotorasib 960mgDrug
Also called Lumykras
Daily dose from day 3 till day 16
| Study group | Role | What they receive |
|---|---|---|
| Single dose rivaroxaban 20 mg and steady-state sotorasib 960 mg | Experimental | To assess the pharmacokinetics of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. Samples will be taken pre-dose (t=0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post ingestion. Receives: Drug: Rivaroxaban 20mg; Drug: Sotorasib 960mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state.
The geometric mean ratios of area under the concentration time curve (AUC) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals. The pharmacokinetics of rivaroxaban will be assessed with standard compartmental or non-compartmental pharmacokinetic methods.
Measured: 18 days
The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state.
Maximum concentration (Cmax) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals. The pharmacokinetics of rivaroxaban will be assessed with standard compartmental or non-compartmental pharmacokinetic methods.
Measured: 18 days
Secondary outcomes (7)
The pharmacokinetics (AUC) of sotorasib in healthy volunteers.
Description of the area under the concentration time curve (AUC) of sotorasib at steady-state conditions in healthy volunteers, by means of standard compartmental or non-compartmental pharmacokinetic methods.
Measured: 18 days
The pharmacokinetics (Cmax) of sotorasib in healthy volunteers.
Description of the maximum concentration (Cmax) of sotorasib at steady-state in healthy volunteers, by means of standard compartmental or non-compartmental pharmacokinetic methods.
Measured: 18 days
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Description of the treatment-related events of sotorasib and rivaroxaban, graded with the most recent version (v6) of the Common Toxicity Criteria for Adverse Events (CTCAE)
Measured: 18 days
Pharmacokinetic variability in AUC of rivaroxaban.
Assess the pharmacokinetic variability in area under the concentration time curve (AUC) of rivaroxaban between healthy subjects
Measured: 18 days
Pharmacokinetic variability in Cmax of rivaroxaban.
Assess the pharmacokinetic variability in maximal concentration (Cmax) of rivaroxaban between healthy subjects
Measured: 18 days
Pharmacokinetic variability in AUC of sotorasib.
Assess the pharmacokinetic variability in area under the concentration time curve (AUC) of sotorasib between healthy subjects.
Measured: 18 days
Pharmacokinetic variability in Cmax of sotorasib.
Assess the pharmacokinetic variability in maximal concentration (Cmax) of sotorasib between healthy subjects.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start9 Nov 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Drug Interaction StudyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label single-sequence pharmacokinetic drug-drug interaction study.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Rob ter Heine, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314763
- Sponsor's protocol ID
- ROSIE
- Acronym
- ROSIE
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hollander EM, Buma AIG, Leentjens J, Janssen PKC, van den Heuvel MM, Burger DM, Piet B, Ter Heine R. No relevant pharmacokinetic interaction between the KRAS G12C inhibitor sotorasib and the direct oral anticoagulant rivaroxaban in healthy subjects. Int J Cancer. 2026 Jun 1;158(11):2920-2927. doi: 10.1002/ijc.70326. Epub 2026 Jan 19.
PubMed 41552958
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Sotorasib Interaction Study
- ClinicalTrials.gov ID
- NCT06314763
- Acronym / sponsor ID
- ROSIE / ROSIE
- Conditions
- Drug Drug Interaction Study
- Keywords
- Lung cancer, Non small cell lung cancer, NSCLC, Sotorasib, Lumykras, Lumakras, Rivaroxaban, Xarelto
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (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.
Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of >15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US [FDA] and EU [EMA] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs.
Detailed description
Objective:
To assess the pharmacokinetics of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state
Main study parameters/endpoints:
The geometric mean ratios of area under the concentration time curve (AUC) and maximum concentration (Cmax) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals.
Study design:
An open label single-sequence pharmacokinetic drug-drug interaction study in healthy volunteers.
Study population:
Healthy human volunteers aged between 18 and 65. Volunteers can't participate in this study if they have an increased risk for bleeding or blood clotting. Furthermore, volunteers receiving concomitant drugs with a pharmacokinetic or pharmacodynamic interaction with the investigational medicinal products will also be excluded.
Intervention:
The pharmacokinetics of a single dose rivaroxaban are assessed in presence and absence of sotorasib. The study participants will receive rivaroxaban (20 mg single dose ingested with food) on day 1, followed by a wash-out period on day 1 and 2, followed by daily administration of sotorasib 960 mg once daily on day 3-16 and rivaroxaban (20 mg single dose ingested with food) on day 16.
The pharmacokinetics of rivaroxaban will be assessed at T=0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration on the days that rivaroxaban is administered.
The pharmacokinetics of sotorasib will be assessed at T=0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24h after administration on day 16.
Ethical consideration to the clinical trial including the expected benefit to the individual subject or group of patients represented by the study participants as well as the nature and extent of burden and risks: A drug-drug interaction study in patients on sotorasib is not considered feasible and methodologically sound, due to high co-morbidity and polypharmacy in patients with an indication for treatment with sotorasib. Single dose pharmacokinetic rivaroxaban studies in healthy volunteers are common and the gold standard to assess the impact of drug-drug interactions with DOACs. Single and multiple dose studies of sotorasib in healthy volunteers are considered and proven safe, likely due to high selectivity of the drug for KRAS G12C mutation that is only present in tumor cells of individuals with KRAS G12C mutated cancer. There is no individual benefit for participation in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label single-sequence pharmacokinetic drug-drug interaction study.
| Arm | Type | Receives |
|---|---|---|
| Single dose rivaroxaban 20 mg and steady-state sotorasib 960 mg | Experimental | Drug: Rivaroxaban 20mg, Drug: Sotorasib 960mgTo assess the pharmacokinetics of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. Samples will be taken pre-dose (t=0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post ingestion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 and not older than 65 years at screening.
- Subject does not smoke more than 10 (e-)cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first study day.
- Subject has a Body Mass Index of 18 to 30 kg/m2 .
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is in good age-appropriate health condition as established by medical history and physical examination within 4 weeks prior to day 1.
Key exclusion criteria (30 listed)
- An estimated glomerular filtration or creatinine clearance of less than 70mL/min.
- Liver enzyme tests (ALAT, ASAT, GGT, total bilirubin, ALP) greater than 2 times the upper limit of normal.
- Serum electrolytes (sodium, potassium, calcium, magnesium) outside the normal range of the NVKC reference ranges.
- Hemocytometric values (hemoglobin, hematocrit, leukocytes, erythrocytes and thrombocytes) outside of the NVKC reference ranges.
- A prothrombin time (PT) > 13.3 seconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 20mgAlso: XareltoSingle dose on day 1 and day 16 | Drug | Single dose rivaroxaban 20 mg and steady-state sotorasib 960 mg |
| Sotorasib 960mgAlso: LumykrasDaily dose from day 3 till day 16 | Drug | Single dose rivaroxaban 20 mg and steady-state sotorasib 960 mg |
Primary outcome
The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state.
Time frame: 18 days
The geometric mean ratios of area under the concentration time curve (AUC) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals. The pharmacokinetics of rivaroxaban will be assessed with standard compartmental or non-compartmental pharmacokinetic methods.
The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state.
Time frame: 18 days
Maximum concentration (Cmax) of rivaroxaban in absence and presence of sotorasib, and their corresponding 90% confidence intervals. The pharmacokinetics of rivaroxaban will be assessed with standard compartmental or non-compartmental pharmacokinetic methods.
7 secondary outcomes
The pharmacokinetics (AUC) of sotorasib in healthy volunteers.
Time frame: 18 days
The pharmacokinetics (Cmax) of sotorasib in healthy volunteers.
Time frame: 18 days
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: 18 days
Pharmacokinetic variability in AUC of rivaroxaban.
Time frame: 18 days
Pharmacokinetic variability in Cmax of rivaroxaban.
Time frame: 18 days
Pharmacokinetic variability in AUC of sotorasib.
Time frame: 18 days
Pharmacokinetic variability in Cmax of sotorasib.
Time frame: 18 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 30 Apr 2024.
- Derived from this study: PubMed 41552958Hollander EM, Buma AIG, Leentjens J, Janssen PKC, van den Heuvel MM, Burger DM, Piet B, Ter Heine R. No relevant pharmacokinetic interaction between the KRAS G12C inhibitor sotorasib and the direct oral anticoagulant rivaroxaban in healthy subjects. Int J Cancer. 2026 Jun 1;158(11):2920-2927. doi: 10.1002/ijc.70326. Epub 2026 Jan 19.
- 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.
Rob ter Heine principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 20mg and Sotorasib 960mg in people with Drug Drug Interaction Study, run by Radboud University Medical Center at 1 site 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 30 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. (time frame: 18 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?
On the ClinicalTrials.gov record for NCT06314763, which also lists 1 linked publication.
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 30 Apr 2024.