Renal Cell Carcinoma (RCC) Clinical Trials

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Cabozantinib Dose Skipping as an Alternative to Dose Reductions

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
LUMC
RECRUITING
Leiden
Contact Information
Primary
Tom van der Hulle, MD PhD
t.van_der_hulle@lumc.nl
0031715263464
Backup
Nikki Kerssemakers, MSc
n.kerssemakers@lumc.nl
0031683139525
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 34
Treatments
Active_comparator: Standard regimen
taking 20mg or 40mg cabozantinib once daily with standard breakfast.
Related Therapeutic Areas
Sponsors
Leads: dr. Tom van der Hulle

This content was sourced from clinicaltrials.gov