Population Pharmacokinetics of Cabozantinib in Metastatic Renal Cell Carcinoma Patients: Towards Drug Expenses Saving Regimens.
Zhiyuan Tan, Swantje Völler, Anyue Yin...
https://pubmed.ncbi.nlm.nih.gov/38874883Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07077161
Cabozantinib Dose Skipping as an Alternative to Dose Reductions in Metastatic Renal Cell Carcinoma
Led by dr. Tom van der Hulle · Updated on 2026-01-28
34
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether alternative dosing schedules of cabozantinib provide similar drug exposure compared to standard dosing in patients with metastatic renal cell carcinoma (mRCC). The study aims to see if using fewer tablets, given cabozantinib's slow elimination and uniform pricing across dosages, could reduce costs while maintaining similar effectiveness and impact on side effects and quality of life. Participants will receive cabozantinib either by the standard regimen—20mg or 40mg once daily with a standard breakfast—or an experimental regimen. The experimental regimen for 20mg users involves taking 60mg for one day followed by two days without medication; for 40mg users, it involves taking 60mg for two days followed by one day off. Each dosing period lasts four weeks before switching to the other regimen. During the study, participants will visit the clinic multiple times to provide blood samples and complete questionnaires about their quality of life and side effects. Blood samples are collected after each dosing period and on days 1 and 3 post-visit to assess drug exposure. The study measures include comparing drug levels, quality of life scores, side effects like nausea or diarrhea, and patient preferences over approximately two months of participation.
CONDITIONS
Brief Title
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
Who Can Participate
Age: 18Years +
All Genders
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 and the need for dose reductions or treatment interruptions has been estimated as low
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Estimated life expectancy of 6 months
- No response evaluation planned during the study period
You will not qualify if you...
- Inability to follow the recommended standard breakfast
- Gastrointestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel disease, malabsorption syndrome, and prior major surgery of the stomach, pancreas, liver or small bowel
- Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grapefruit juice, clarithromycin, erythromycin, itraconazole and ritonavir
- 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
- Use of inhibitor of multidrug resistance-associated protein 2 within 1 month of start of treatment with cabozantinib, including cyclosporine, delavirdine, efavirenz, emtricitabine, benzbromarone and probenecid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 2 months
Participants take cabozantinib following either the standard daily dosing regimen or an experimental dose skipping regimen with breakfast.
Trial Site Locations
Total: 1 location
1
LUMC
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
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Research Team
T
Tom van der Hulle, MD PhD
N
Nikki Kerssemakers, MSc
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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