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Cabozantinib Dose Skipping as an Alternative to Dose Reductions

NCT07077161 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Renal Cell Carcinoma (RCC)

Interventions

DRUG

Cabozantinib

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.

Sponsors & Collaborators

  • dr. Tom van der Hulle

    lead OTHER

Principal Investigators

  • Tom van der Hulle, MD PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-09-01
Completion
2028-09-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077161 on ClinicalTrials.gov