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Intensified Monitoring of PhArmacology of Cabozantinib as a Tool for Toxicity Management in Patients With Renal Cell Carcinoma
Sponsor: Centro di Riferimento Oncologico - Aviano
Summary
Adverse events (AEs) with Cabozantinib are frequent (about 40-67% of patients) and often lead to temporary treatment interruptions, dose reductions or permanent discontinuations, potentially reducing dose intensity and sustained exposure. Therefore, strategies are needed to improve tolerability without compromising antitumor activity. Therapeutic drug monitoring (TDM) is particularly suitable for drugs with high interpatient variability, narrow therapeutic windows and defined exposure-response relationships; real world data support this profile for Cabozantinib and suggest that pharmacokinetically guided dosing could help manage toxicity while maintaining efficacy. Based on this evidence, the study proposes a model of individualized pharmacological counselling integrating TDM, pharmacogenetic testing and structured evaluation of pharmacological interactions to optimize Cabozantinib exposure and minimize avoidable toxicity.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2026-05-19
Completion Date
2030-05-19
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
Intensified Monitoring of Pharmacology
individualized pharmacological counselling integrating TDM, pharmacogenetic testing and structured evaluation of pharmacological interactions
Locations (1)
Centro di Riferimento Oncologico, CRO-IRCCS
Aviano, Pordenone, Italy