Cabozantinib Dose Skipping as an Alternative to Dose Reductions

Sponsor
dr. Tom van der Hulle
Study ID
NCT07077161
Phase
PHASE2
Status
Recruiting
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Conditions

  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard regimen
    taking 20mg or 40mg cabozantinib once daily with standard breakfast.

Primary Outcome Measure

Comparison of the AUC0-72h of the experimental and the standard regimen. [ Time Frame: From enrollment to the end of the study at approximately 2 months ]

Central Contacts

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