A Phase 2 interventional study of Light breakfast in Renal Cell Carcinoma, sponsored by dr. Tom van der Hulle. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by dr. Tom van der Hulle · Phase 2, Interventional, and Treatment
Cabozantinib is a drug which is used to treat metastasized kidney cancer. While it works well, it has a lot of side effects and is quite expensive (€213,- every tablet, €6403,- every month). The standard recommended dose is 60 mg once a day, taken in fasted state. This means patients are not allowed to eat at least 2 hours before and one hour after taking cabozantinib. In daily practice, this is difficult for patients. It might be that by taking with breakfast the chance of side effects like nausea and diarrhea decreases. If patients take cabozantinib with breakfast, the body will have a higher uptake of the drug.
Often the dose of cabozantinib has to be lowered due to side effects. All tablets cabozantinib have the same price, despite how many milligrams are in the tablets. Cabozantinib stays in the body for a long time after ingestion. It takes approximately 120 hours before half of the medicine has left the body. This means it might not be necessary to take cabozantinib every day. Therefore, it is interesting to investigate if taking cabozantinib with breakfast makes it possible to skip taking cabozantinib once in a while. In this study, the investigators want to investigate to what extent the exposure of cabozantinib increases after ingestion with a light breakfast. The results from this study will be used for the development of alternative dosing regimens with cabozantinib tablets of 60 mg taken with a light breakfast including skipping days.
In this study, patients will randomized to start with taking cabozantinib in fasted state (standard regimen) and taking cabozantinib with a light breakfast (experimental regimen). Menu options will be provided. After at least 4 weeks taking cabozantinib according to the randomized regimen, patients will be submitted to the hospital for one day to measure the amount of cabozantinib in the blood at several points of time. This will be measured by venepuncture and fingerprick microsampling. When all blood samples have been collected, the patient will switch to the other regimen. After at least 4 weeks taking cabozantinib according to the second regimen, venous blood samples will be collected in exactly the same way. After all patients have completed the study, an analysis will be performed to determine the change in exposure to cabozantinib when it is taken with a light breakfast. The results will be used in order to determine the definitive experimental dosing regimens that will be investigated a subsequent study. Patients will be monitored for side effects, especially nausea and/or diarrhea.
The primary goal is to investigate to what extent the exposure of cabozantinib increases by taking cabozantinib with a light breakfast compared to taking cabozantinib in fasted state. The secondary objective is to investigate the analytical feasibility of microsampling (finger prick) for cabozantinib concentration measurements and to monitor side effects.
1,964 studies on the registry are indexed under Carcinoma, Renal Cell; 377 are open to participants now.
This study's enrollment of 12 is below the median of 42 across 1,479 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →dr. Tom van der Hulle is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients will continue to use cabozantinib in fasted state, as part of standard of care, in the recommended dose as prior to enrollment in the study.
Patients will take the prior recommended dose cabozantinib with a light breakfast.
Other: Light breakfast
Light breakfast, standardized by 7 menu options for patients. All breakfast options contain the same amount of fat (9-10 g). Example of a menu: 150 ml full-fat yoghurt, 40 gram muesli with sugar, 1 glass of tea.
Area under the concentration-time curve (AUC)
Increase of the area under the concentration-time curve (AUC) of the experimental regimen compared to the standard regimen
Time frame: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4, 5, 6, 8 and 24 hours)
Analytical feasibility
Analytical correlation/agreement between venapuncture (plasma) measurements and microsampling (whole blood and capillary plasma) measurements
Time frame: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4)
Adverse events
The total number of patients experiencing (S)AEs
Time frame: At inclusion and at both hospital admissions after at least 28 days on the regimen
Plan to share: Undecided — To be determined in detail
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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dr. Tom van der Hulle