Renal Cell CarcinomaIMPACTNCT07805122
Intensified Monitoring of PhArmacology of Cabozantinib as a Tool for Toxicity Management in Patients With Renal Cell Carcinoma
A study testing Intensified Monitoring of Pharmacology in people with Renal Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Intensified Monitoring of Pharmacology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2026to 19 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear cell subtype.
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive systemic treatment with nivolumab + Cabozantinib or Cabozantinib monotherapy as per clinical practice (investigators choice).
- Signed Written Informed Consent.
- Male or female subjects aged ≥18 years old.
- Women of childbearing potential must avoid pregnancy while on Cabozantinib. Female partners of male patients taking Cabozantinib must also avoid pregnancy. Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might possibly not be considered as "effective methods of contraception", due to factors such as missed doses, gastrointestinal disturbances, or potential drug interactions that could reduce their effectiveness, they should be used together with another method, such as a barrier method.
- Previous nephrectomy is permitted.
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- All IMDC (International Metastatic RCC Database Consortium) risk (good, intermediate, poor).
- Eastern Cooperative Oncology Group performance status 0 or 1
- Capable of understanding and complying with the protocol requirements.
- patients will be included in the study regardless of their time of treatment start with Cabozantinib and regardless of their concomitant diseases or co-medication.
- Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear cell subtype.
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive systemic treatment with nivolumab + Cabozantinib or Cabozantinib monotherapy as per clinical practice (investigators choice).
Who cannot join
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention.
- Pregnancy status.
- Refusal of informed consent.
- Patients who could not attend periodic clinical check-ups.
- Any condition that, in the investigator's judgment, could compromise appropriate participation in the study.
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico, CRO-IRCCS
Aviano, Pordenone, 33081
Erika Cecchin, PhD, PharmD, 0434659667, ececchin@cro.it
Erika Cecchin, PhD, PharmD
About this study
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Intensified Monitoring of Pharmacology
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified Monitoring of PharmacologyOther
individualized pharmacological counselling integrating TDM, pharmacogenetic testing and structured evaluation of pharmacological interactions
| Study group | Role | What they receive |
|---|---|---|
| historical control group | No intervention | Not described |
| interventional group | Experimental | Not described Receives: Other: Intensified Monitoring of Pharmacology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 months
Secondary outcomes (18)
Attitude Towards Pharmacological Counseling Among Oncologists
Rate of adherence to pharmacological counseling recommendations.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: up to 48 months
Characterization of the Exposure-Toxicity Relationship
Sensitivity and specificity of Cmin cut-off values for predicting adverse events.
Measured: 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;
Measured: 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.
Measured: 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;
Measured: 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.
Measured: 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
Measured: up to 48 months
Explore molecular biomarker expression patterns in patients starting Cabozantinib therapy for future stratification of toxicity risk.
Absolute and relative frequencies
Measured: 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.
Measured: up to 48 months
Evaluate influence of covariates (sex, inflammation, genetic polymorphisms) on Cabozantinib PK.
Linear regression coefficient with relative 95% CI.
Measured: 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.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start19 May 2026
- Primary completion19 May 2030 (estimated)
- Study completion19 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805122
- Sponsor's protocol ID
- CRO-2026-06
- Acronym
- IMPACT
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Monitoring of PhArmacology of Cabozantinib as a Tool for Toxicity Management in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07805122
- Acronym / sponsor ID
- IMPACT / CRO-2026-06
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 19 May 2030 (estimated)
- Study completion
- 19 May 2030 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| historical control group | No intervention | – |
| interventional group | Experimental | Other: Intensified Monitoring of Pharmacology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear cell subtype.
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive systemic treatment with nivolumab + Cabozantinib or Cabozantinib monotherapy as per clinical practice (investigators choice).
- Signed Written Informed Consent.
- Male or female subjects aged ≥18 years old.
- Women of childbearing potential must avoid pregnancy while on Cabozantinib. Female partners of male patients taking Cabozantinib must also avoid pregnancy. Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might possibly not be considered as "effective methods of contraception", due to factors such as missed doses, gastrointestinal disturbances, or potential drug interactions that could reduce their effectiveness, they should be used together with another method, such as a barrier method.
Key exclusion criteria (8 listed)
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention.
- Pregnancy status.
- Refusal of informed consent.
- Patients who could not attend periodic clinical check-ups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified Monitoring of Pharmacologyindividualized pharmacological counselling integrating TDM, pharmacogenetic testing and structured evaluation of pharmacological interactions | Other | interventional group |
Primary outcome
Impact of the systematic pharmacological counseling activity intervention on Cabozantinib related toxicity
Time frame: up to 48 months
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.
18 secondary outcomes
Attitude Towards Pharmacological Counseling Among Oncologists
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
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
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
Time frame: up to 48 months
Explore accuracy of a point-of-care testing (POCT) device for Cabozantinib TDM.
Time frame: up to 48 months
Explore precision of a point-of-care testing (POCT) device for Cabozantinib TDM.
Time frame: up to 48 months
Explore the linearity of a point-of-care testing (POCT) device for Cabozantinib TDM.
Time frame: up to 48 months
Explore comparability of a a point-of-care testing (POCT) device for Cabozantinib TDM with LC-MS method
Time frame: up to 48 months
Characterization of the Exposure-Toxicity Relationship
Time frame: up to 48 months
Assess associations between germline polymorphisms in genes related to Cabozantinib pharmacokinetics and drug exposure levels
Time frame: up to 48 months
Assess associations between germline polymorphisms in genes related to Cabozantinib pharmacokinetics and treatment-related toxicities.
Time frame: up to 48 months
Investigate the association between inflammatory biomarkers (CRP, IL-6, IL-1β, TNF-α, IFN-γ) and Cabozantinib exposure
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.
Time frame: up to 48 months
Measure ctDNA levels via shallow whole-genome sequencing (liquid biopsy) as a tool for monitoring disease response.
Time frame: up to 48 months
Explore molecular biomarker expression patterns in patients starting Cabozantinib therapy for future stratification of toxicity risk.
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.
Time frame: up to 48 months
Evaluate influence of covariates (sex, inflammation, genetic polymorphisms) on Cabozantinib PK.
Time frame: up to 48 months
develop a PK/PD model describing the exposure-response and exposure-toxicity relationships for Cabozantinib.
Time frame: up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified Monitoring of Pharmacology in people with Renal Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Cecchin, PhD, PharmD (0434659667, ececchin@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the systematic pharmacological counseling activity intervention on Cabozantinib related toxicity (time frame: up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.