The CetuxIMAX protocol: a non-interventional, uncontrolled, and non-comparative multicentric study for exploring the pharmacokinetics/pharmacodynamics relationships of cetuximab in head and neck cancer patients

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dc.contributor.authorMarin, Clemenceen_US
dc.contributor.authorCiccolini, Josephen_US
dc.contributor.authorLacarelle, Brunoen_US
dc.contributor.authorAuquier, Pascalen_US
dc.contributor.authorSalass, Sebastienen_US
dc.date.accessioned2024-09-24T07:20:19Z
dc.date.available2024-09-24T07:20:19Z
dc.date.issued2023-12
dc.description.abstractBackground: In a previous pilot-study, a link between Cetuximab exposure levels (i.e., trough levels above 34 mg/ml) and clinical outcome in head and neck cancer patients was found. Considering the high inter-individual variability in Cetuximab plasma levels, lack of efficacy could thus be linked to inadequate exposure levels, rather than issues with signalling pathways at the tumor level. Methods: The CetuxIMAX study is a non-interventional, uncontrolled, and non-comparative multicentric study in patients with recurrent or metastatic head and neck squamous cell carcinoma, and treated by any Cetuximab-based regimen. A total of 122 patients will be enrolled in this study. The primary endpoint is the estimation of receiver operating characteristic (ROC) and area under the ROC curve (AUROC) of Cetuximab trough plasma level for the disease control rate (DCR). Pharmacokinetics samples will be collected at first cycle, when steady-state is reached, and during maintenance phase to monitor the Cetuximab levels throughout time. Standard PK modelling using population-approach will be performed to identify individual PK parameters and enable further simulations of exposure levels throughout the different cycles. Univariate and multivariable statistical analysis aiming at exploring any association between Cetuximab exposure levels and clinical outcome will be performed. Conclusions: Should the target therapeutic window associated with efficacy be confirmed with Cetuximab in head/neck cancer patients, this could pave the way for PK-guided dosing next. Based upon single point PK sampling, pop-PK modelling could help personalizing dosing or scheduling, to ensure an optimal toxicity-efficacy ratio with Cetuximab. Trial Registration: Trial registration number is NCT 04218136.en_US
dc.identifier.affiliationsClinical Pharmacokinetics Laboratory, La Timone University Hospital of Marseille, Marseille, France; SMARTc, Inserm U1068 CRCM, Aix-Marseille-University, Marseille France; COMPO, INRIA-Inserm CRCM, Aix-Marseille-University, Marseille, Franceen_US
dc.identifier.affiliationsClinical Pharmacokinetics Laboratory, La Timone University Hospital of Marseille, Marseille, France; SMARTc, Inserm U1068 CRCM, Aix-Marseille-University, Marseille France; COMPO, INRIA-Inserm CRCM, Aix-Marseille-University, Marseille, Franceen_US
dc.identifier.affiliationsClinical Pharmacokinetics Laboratory, La Timone University Hospital of Marseille, Marseille, Franceen_US
dc.identifier.affiliationsDepartment of Statistics, EA 3279 CERESS, Aix-Marseille-University, Marseille, Franceen_US
dc.identifier.affiliationsCOMPO, INRIA-Inserm CRCM, Aix-Marseille-University, Marseille, France; Medical Oncology Unit, La Timone University Hospital of Marseille, Marseille, Franceen_US
dc.identifier.citationMarin Clemence,Ciccolini Joseph, Lacarelle Bruno, Auquier Pascal, Salass Sebastien . The CetuxIMAX protocol: a non-interventional, uncontrolled, and non-comparative multicentric study for exploring the pharmacokinetics/pharmacodynamics relationships of cetuximab in head and neck cancer patients. International Journal of Clinical Trials. 2023 Oct. 10(4). 311-317en_US
dc.identifier.issn349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/228797
dc.languageenen_US
dc.relation.issuenumber4en_US
dc.relation.volume10en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20233175en_US
dc.subjectCetuximaben_US
dc.subjectPharmacokineticsen_US
dc.subjectHead and neck canceren_US
dc.subjectModellingen_US
dc.titleThe CetuxIMAX protocol: a non-interventional, uncontrolled, and non-comparative multicentric study for exploring the pharmacokinetics/pharmacodynamics relationships of cetuximab in head and neck cancer patientsen_US
dc.typeJournal Articleen_US
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