protocolSection identificationModule nctId: NCT06314763, orgStudyIdInfo id: ROSIE, briefTitle: Rivaroxaban Sotorasib Interaction Study, acronym: ROSIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-09, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: Amgen, descriptionModule briefSummary: 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., conditionsModule conditions: Drug Drug Interaction Study, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: An open label single-sequence pharmacokinetic drug-drug interaction study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban 20mg, interventions name: Sotorasib 960mg, outcomesModule primaryOutcomes measure: The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state., primaryOutcomes measure: The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state., secondaryOutcomes measure: The pharmacokinetics (AUC) of sotorasib in healthy volunteers., secondaryOutcomes measure: The pharmacokinetics (Cmax) of sotorasib in healthy volunteers., secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v6.0, secondaryOutcomes measure: Pharmacokinetic variability in AUC of rivaroxaban., secondaryOutcomes measure: Pharmacokinetic variability in Cmax of rivaroxaban., secondaryOutcomes measure: Pharmacokinetic variability in AUC of sotorasib., secondaryOutcomes measure: Pharmacokinetic variability in Cmax of sotorasib., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud university medical centre, status: RECRUITING, city: Nijmegen, country: Netherlands, contacts name: Rob ter Heine, role: CONTACT, email: R.terHeine@radboudumc.nl, contacts name: Rob ter Heine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False