Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma

Condition studied

Renal cell carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

The impact of the counseling intervention on Cabozantinib related toxicity will be evaluated as the overall reduction of the frequency of treatment interruptions due to clinically relevant toxicity in RCC patients treated with Cabozantinib, compared to historical data.

Endpoint detail

Rate of adherence to pharmacological counseling recommendations., Analytical performance parameters (accuracy, precision, linearity, LLOQ, stability)., Analytical performance parameters (accuracy, precision, linearity, LLOQ, stability). Comparability with LC-MS method., Sensitivity and specificity of Cmin cut-off values for predicting adverse events., Mean/median Cmin difference according to genetic variants., Incidence/severity of treatment-related adverse events according to genetic variants., Mean/median Cmin difference according to inflammatory marker levels., Inflammatory marker levels according to incidence/severity of adverse events., Mean/median values over time., Mean/median difference in ctDNA levels according to disease progression/response., Absolute and relative frequencies., Predictive performance of model-based vs. log-linear extrapolation TDM approaches., Linear regression coefficient with relative 95% CI., Linear regression coefficient with relative 95% CI.