An interventional study of Intensified Monitoring of Pharmacology in Renal Cell Carcinoma, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Centro di Riferimento Oncologico - Aviano · Not applicable, Interventional, and Other
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.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 216 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 51 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria for intervention group:
Inclusion criteria for the historical control group:
Exclusion criteria for the historical control group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Intensified Monitoring of Pharmacology
individualized pharmacological counselling integrating TDM, pharmacogenetic testing and structured evaluation of pharmacological interactions
This study also gives Cabozantinib. No intervention listed here names it: that was found by reading the record.
Impact of the systematic pharmacological counseling activity intervention on Cabozantinib related toxicity
The impact will be evaluated as the overall change of the frequency of treatment interruptions due to clinically relevant toxicity in RCC (Renal cell carcinoma) patients treated with Cabozantinib, compared to historical data.
Time frame: up to 48 months
Attitude Towards Pharmacological Counseling Among Oncologists
Rate of adherence to pharmacological counseling recommendations.
Time frame: up to 48 months
Validate LC-MS/MS methods for Cabozantinib quantification in plasma and dried blood spot (Capitainer B and Hemaxis) in terms of accuracy
Accuracy will be evaluated as difference between results obtained by the method to the nominal concentration of the analyte in the biological matrix
Time frame: up to 48 months
Validate LC-MS/MS methods for Cabozantinib quantification in plasma and dried blood spot (Capitainer B and Hemaxis) in terms of precision
Precision will be evaluated as Coefficient of Variation (CV) calculated as standard deviation/mean values
Time frame: up to 48 months
Validate LC-MS/MS methods for Cabozantinib quantification in plasma and dried blood spot (Capitainer B and Hemaxis) in terms of linearity
Linearity will be evaluated using squared R to assess the goodness of fit of the calibration curve
Time frame: up to 48 months
Explore accuracy of a point-of-care testing (POCT) device for Cabozantinib TDM.
Accuracy will be evaluated as difference between results obtained by the method to the nominal concentration of the analyte in the biological matrix
Time frame: up to 48 months
Explore precision of a point-of-care testing (POCT) device for Cabozantinib TDM.
Precision will be evaluated as Coefficient of Variation (CV) calculated as standard deviation/mean values
Time frame: up to 48 months
Explore the linearity of a point-of-care testing (POCT) device for Cabozantinib TDM.
Linearity will be evaluated using squared R to assess the goodness of fit of the calibration curve
Time frame: up to 48 months
Explore comparability of a a point-of-care testing (POCT) device for Cabozantinib TDM with LC-MS method
Comparability will be evalueted with Bland Altman analysis.
Time frame: up to 48 months
Characterization of the Exposure-Toxicity Relationship
Sensitivity and specificity of Cmin cut-off values for predicting adverse events.
Time frame: up to 48 months
Assess associations between germline polymorphisms in genes related to Cabozantinib pharmacokinetics and drug exposure levels
Mean/median Cmin difference according to genetic variants;
Time frame: up to 48 months
Assess associations between germline polymorphisms in genes related to Cabozantinib pharmacokinetics and treatment-related toxicities.
Incidence/severity of treatment-related adverse events according to genetic variants.
Time frame: up to 48 months
Investigate the association between inflammatory biomarkers (CRP, IL-6, IL-1β, TNF-α, IFN-γ) and Cabozantinib exposure
Mean/median Cmin difference according to inflammatory marker levels;
Time frame: up to 48 months
Investigate the association between inflammatory biomarkers (CRP, IL-6, IL-1β, TNF-α, IFN-γ) and Cabozantinib adverse events.
inflammatory marker levels according to incidence/severity of adverse events.
Time frame: up to 48 months
Measure ctDNA levels via shallow whole-genome sequencing (liquid biopsy) as a tool for monitoring disease response.
Mean/median values over time; Mean/median difference in ctDNA levels according to disease progression/response
Time frame: up to 48 months
Explore molecular biomarker expression patterns in patients starting Cabozantinib therapy for future stratification of toxicity risk.
Absolute and relative frequencies
Time frame: up to 48 months
Assess the feasibility of model-based therapeutic drug monitoring and compare it to the traditional log-linear extrapolation method for estimating Cabozantinib Cmin.
Predictive performance of model-based vs. log-linear extrapolation TDM approaches.
Time frame: up to 48 months
Evaluate influence of covariates (sex, inflammation, genetic polymorphisms) on Cabozantinib PK.
Linear regression coefficient with relative 95% CI.
Time frame: up to 48 months
develop a PK/PD model describing the exposure-response and exposure-toxicity relationships for Cabozantinib.
Linear regression coefficient with relative 95% CI.
Time frame: up to 48 months
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Centro di Riferimento Oncologico - Aviano