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

Conditions

Renal cell carcinoma

Brief summary

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.

Detailed description

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.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCabozantinib Ipsen 40 mg film-coated tablets

DRUGCabozantinib Ipsen 20 mg film-coated tablets

DRUGCabozantinib Ipsen 60 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Outcome results

None listed