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/38874883/Actively Recruiting
Led by dr. Tom van der Hulle · Updated on 2026-01-28
34
Participants Needed
1
Research Sites
52 weeks
Total Duration
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 cabozantinibs 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 regimen20mg or 40mg once daily with a standard breakfastor 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
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
T
Tom van der Hulle, MD PhD
N
Nikki Kerssemakers, MSc
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dr. Tom van der Hulle
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 months
Participants take cabozantinib following either the standard daily dosing regimen or an experimental dose skipping regimen with breakfast.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
1
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Zhiyuan Tan, Swantje Völler, Anyue Yin...
https://pubmed.ncbi.nlm.nih.gov/38874883/dr. Tom van der Hulle
Lead Sponsor