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RECRUITING
NCT07805122
NA

Intensified Monitoring of PhArmacology of Cabozantinib as a Tool for Toxicity Management in Patients With Renal Cell Carcinoma

Sponsor: Centro di Riferimento Oncologico - Aviano

View on ClinicalTrials.gov

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

Interventions

OTHER

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