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

Study acronym: IMPACT
StatusRecruiting
PhaseNot applicable
Started2026-05-19
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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.
Trial Details
NCT Number NCT07805122
Lead Sponsor Centro di Riferimento Oncologico - Aviano
Conditions Renal Cell Carcinoma
Enrollment 216 participants
Start Date 2026-05-19
Primary Completion 2030-05-19 (estimated)
Study Completion 2030-05-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-04