RecruitingPhase 2NCT07077161

Cabozantinib Dose Skipping as an Alternative to Dose Reductions

Sponsor

dr. Tom van der Hulle

Enrollment

34 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (RCC)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether skipping an occasional dose of cabozantinib (instead of permanently reducing the dose) is a safe and effective way to manage side effects in people with advanced kidney cancer who are already tolerating it well. **You may be eligible if...** - You are 18 years or older - You have confirmed advanced renal cell carcinoma (kidney cancer) - You have been on a stable dose of cabozantinib (40mg or 20mg daily, alone or with nivolumab) for at least 4 weeks - Your treatment has been going well with a low likelihood of needing dose reductions - Your overall health is adequate (ECOG 0–2) and life expectancy is at least 6 months **You may NOT be eligible if...** - You have gastrointestinal problems that affect how your body absorbs cabozantinib (such as inflammatory bowel disease or malabsorption) - You are unable to follow a standard breakfast routine (required for consistent drug absorption) - A response evaluation (scan) is planned during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib

For patients using 40mg the experimental regimen consists of 60mg once daily for 2 days followed by 1 skipping day (60-60-0 mg). For patients using 20mg the experimental regimen consists of 60mg once daily for 1 day followed by 2 skipping days (60-0-0 mg). In both cases cabozantinib is also taken with standard breakfast.