Actively Recruiting
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
Led by dr. Tom van der Hulle · Updated on 2026-01-28
34
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to determine if an alternative cabozantinib dosing regimens results in a similar drug exposure compared to the standard regimens in patients with metastatic renal cell carcinoma (mRCC). All dosages of cabozantinib (20 ,40, 60mg) have the same price, and cabozantinib is eliminated very slowly by the body. This means that using fewer tablets could potentially lead to cost savings, while remaining equally effective. The main questions it aims to answer are: * Is the drug exposure from our experimental regimens similar to the standard dosing regimens? * Do the experimental regimens affect the number of side effect and the patients' quality of life? Participants will: * Take cabozantinib according to either the experimental or standard dosage regimen for 4 weeks * After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires. * 1 and 3 days after this visit: visit the clinic to collect 1 blood sample. * The day after the hospital visit: switch to the other dosing regimen and according to that regimen for another 4 weeks. * After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires * 1 and 3 days after this visit: visit the clinic to collect 1 blood sample.
CONDITIONS
Official Title
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Aged 18 years or older
- Histologically confirmed advanced renal cell carcinoma
- 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
- Acceptable tolerability with low estimated need for dose reductions or treatment interruptions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Estimated life expectancy of 6 months or more
- No response evaluation planned during the study period
You will not qualify if you...
- Inability to follow the recommended standard breakfast
- Gastrointestinal abnormalities affecting cabozantinib absorption, including active inflammatory bowel disease, malabsorption syndrome, or prior major surgery of stomach, pancreas, liver, or small bowel
- Use of moderate or strong inhibitors of cytochrome P450 enzymes within 1 month before starting cabozantinib, including ketoconazole, grapefruit juice, clarithromycin, erythromycin, itraconazole, and ritonavir
- Use of moderate or strong inducers of cytochrome P450 enzymes within 1 month before starting cabozantinib, including rifampicin, phenytoin, carbamazepine, phenobarbital, and herbal products containing St. John's Wort
- Use of inhibitors of multidrug resistance-associated protein 2 within 1 month before starting cabozantinib, including cyclosporine, delavirdine, efavirenz, emtricitabine, benzbromarone, and probenecid
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
LUMC
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
Research Team
T
Tom van der Hulle, MD PhD
CONTACT
N
Nikki Kerssemakers, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
1
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