Cabozantinib for Renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Willing and able to provide informed consent"}
• {"criterion_text":"- Aged 18 years or older"}
• {"criterion_text":"- Histologically confirmed advanced renal cell carcinoma"}
• {"criterion_text":"- At least 4 weeks on a stable dosage of cabozantinib of 40 mg or 20 mg once daily as single agent treatment or in combination with nivolumab"}
• {"criterion_text":"- Acceptable tolerability and the need for dose reductions or treatment interruptions has been estimated as low"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2"}
• {"criterion_text":"- Estimated life expectancy of ≥6 months"}
• {"criterion_text":"- No response evaluation planned during the study period"}

Exclusion criteria

• {"criterion_text":"- Inability to follow the recommended standard breakfast"}
• {"criterion_text":"- Gastro-intestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel diseases, malabsorption syndrome and prior major surgery of the stomach, pancreas, liver or smaller bowel"}
• {"criterion_text":"- Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grape fruit juice, clarithromycin, erythromycin, itraconazole and ritonavir"}
• {"criterion_text":"- Use of moderate or strong inducer of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including rifampicin, phenytoin, carbamazepine, phenobarbital and herbal preparations containing St. John’s Wort"}
• {"criterion_text":"- Use of inhibitor of multidrug resistance-associated protein 2 within 1 month of start of treatment with cabozantinib, including cyclosporine, delaviridine, efavirenz, emtricitabine, benzbromarone and probenecid"}

Primary endpoints

• {"endpoint_text":"- Comparison of the area under the concentration-time curve (AUC0-72): calculated by modelling a pharmacokinetic curve from plasma concentrations cabozantinib, obtained by pharmacokinetic samples from 0 to 72 hours after ingestion of cabozantinib. The AUC0-72 of the standard and experimental regimen will be compared. It is defined as comparable if the geometric mean ratio is within the range of 0.8 – 1.25.","definition_or_measurement_approach":"AUC0-72 calculated by modelling a pharmacokinetic curve from plasma concentrations obtained by PK samples from 0 to 72 hours after ingestion; comparability defined as geometric mean ratio within 0.8–1.25."}
• {"endpoint_text":"- Comparison of the blood trough concentration (Ctrough): defined as the plasma concentration of cabozantinib before ingestion of a dose of cabozantinib. The Ctrough of the standard and experimental regimen will be compared. It is defined as comparable if the geometric mean ratio is within the range of 0.8 – 1.25.","definition_or_measurement_approach":"Ctrough defined as plasma concentration before dose; comparability defined as geometric mean ratio within 0.8–1.25."}

Secondary endpoints

• {"endpoint_text":"- Health-care use: both medication use and hospitalisations will be registered from the patients’ hospital records","definition_or_measurement_approach":"Medication use and hospitalisations recorded from hospital records."}
• {"endpoint_text":"- EQ-5D-5L Quality of Life (See Appendix 5): the EQ-5D-5L questionnaire will be taken after at least four weeks on treatment in the first part and after four weeks in the second part.","definition_or_measurement_approach":"EQ-5D-5L questionnaire administered after ≥4 weeks on treatment in parts of the study."}
• {"endpoint_text":"- FKSI-19 Quality of Life (See Appendix 6): the FKSI-19 questionnaire will be taken after at least four weeks on treatment in the first part and after four weeks in the second part.","definition_or_measurement_approach":"FKSI-19 questionnaire administered after ≥4 weeks on treatment in parts of the study."}
• {"endpoint_text":"- Adverse events: defined as any symptom, sign, illness, or untoward experience (including a clinically significant laboratory finding classified as Grade 3 or higher by the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) v5.0) (28) that develops or worsens during the course of the study, whether or not the event is considered related to study drug. Such an event should be recorded as an adverse event only after t","definition_or_measurement_approach":"Adverse events recorded per CTCAE v5.0; includes Grade ≥3 laboratory findings; recorded when they develop or worsen during the study (recording after first dose as per protocol)."}
• {"endpoint_text":"- Percentage of patients preferring to take cabozantinib in fed state: Question whether patients would prefer to continue to take cabozantinib in fed state or to recommence taking cabozantinib in fasted state","definition_or_measurement_approach":"Patient preference assessed by asking whether they prefer fed vs fasted dosing."}

Netherlands

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

3

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands