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Testing Cabozantinib Dose Skipping Schedule Compared to Dose Reduction in Patients with Kidney Cancer Taking Cabozantinib Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with renal cell carcinoma, which is a type of kidney cancer. The treatment being studied is cabozantinib, a medicine that belongs to a group called tyrosine kinase inhibitors, which work by blocking certain proteins that help cancer cells grow. Some patients may also be taking cabozantinib together with another cancer medicine called nivolumab. The purpose of this study is to find out if taking cabozantinib with food on certain days and then skipping days gives similar levels of the medicine in the blood as taking a lower dose every day without food.

Patients taking part in this study must already be taking cabozantinib at a stable dose of either 40 mg or 20 mg once daily for at least four weeks. The study will compare different ways of taking the medicine. Instead of taking a lower dose every day on an empty stomach, patients will take a higher dose of 60 mg with a standard breakfast but will skip taking the medicine on some days. For example, one pattern involves taking the medicine for two days and then skipping one day, while another pattern involves taking it for one day and then skipping two days. During the study, blood samples will be taken to measure the amount of cabozantinib in the blood over a period of 72 hours after taking the medicine.

The study will look at whether the amount of medicine in the blood is similar between the different dosing patterns by measuring the area under the concentration-time curve and the blood trough concentration, which is the level of medicine in the blood just before the next dose. The study will also collect information about side effects, hospital visits, medication use, and quality of life using questionnaires. Patients will be asked whether they would prefer to continue taking cabozantinib with food or return to taking it on an empty stomach. The study is expected to start enrolling patients in October 2025 and finish in October 2027.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will continue taking your current stable dose of cabozantinib for at least 4 weeks. This dose will be either 40 mg once daily or 20 mg once daily, taken without food on an empty stomach.
During this period, blood samples will be collected to measure the concentration of the medication in your body. These samples will be taken at specific times from 0 to 72 hours after you take the medication.
A blood sample will also be taken just before you take your dose to measure the trough concentration, which is the lowest level of medication in your blood.
After completing at least 4 weeks on this treatment, you will be asked to complete two questionnaires about your quality of life: the EQ-5D-5L and the FKSI-19.
Step 2
Experimental treatment period
You will switch to a different dosing schedule where you take cabozantinib 60 mg with a standard breakfast instead of on an empty stomach.
If you were previously taking 40 mg daily, you will now take 60 mg for 2 days, followed by 1 day without taking the medication. This pattern will repeat throughout this period.
If you were previously taking 20 mg daily, you will now take 60 mg for 1 day, followed by 2 days without taking the medication. This pattern will repeat throughout this period.
During this period, blood samples will again be collected to measure the concentration of the medication in your body. These samples will be taken at specific times from 0 to 72 hours after you take the medication.
A blood sample will also be taken just before you take your dose to measure the trough concentration.
After 4 weeks on this new treatment schedule, you will be asked to complete the same two quality of life questionnaires again: the EQ-5D-5L and the FKSI-19.
You will also be asked whether you would prefer to continue taking cabozantinib with food or return to taking it on an empty stomach.
Step 3
Monitoring throughout the trial
Throughout the entire trial period, any new symptoms, signs of illness, or unwanted experiences will be recorded, particularly those that are serious or significant according to standard medical criteria.
Information about any medications you use and any hospital stays will be collected from your hospital records.
No response evaluation or assessment of how your condition is progressing is planned during the study period.

Who can join the trial?

8 criteria

You must be willing and able to give your permission to join the study
You must be 18 years old or older
You must have advanced renal cell carcinoma, which is a type of kidney cancer, confirmed by laboratory examination of tissue samples
You must have been taking a stable dose of cabozantinib, which is a cancer medicine, at either 40 mg or 20 mg once daily for at least 4 weeks. This medicine may be taken alone or together with another medicine called nivolumab
Your treatment must be well tolerated, meaning you are not experiencing severe side effects, and it is expected that you will not need to reduce your dose or stop treatment temporarily
You must have an ECOG performance status of 0 to 2, which is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, 1 means you have some restrictions, and 2 means you can care for yourself but cannot work
Your doctor must estimate that your life expectancy is 6 months or longer
There must be no plans to check how your cancer is responding to treatment during the time you are in the study

Who cannot join the trial?

3 criteria

The study document does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the research study.
Without detailed exclusion criteria listed, it is not possible to identify which medical conditions, medications, or other factors would prevent someone from joining this study.
Generally, clinical trials have rules about who cannot participate to ensure patient safety and accurate results, but these specific details are not included in the available information.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
St. Antonius Ziekenhuis
Verified
Nieuwegein, The Netherlands
Universitair Medisch Centrum Groningen
Verified
Groningen, The Netherlands

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Investigated drugs

Cabozantinib is a cancer treatment medication that works by blocking certain proteins that help cancer cells grow and spread. In this study, it is being tested to see if taking the medication with food on some days and skipping it on other days gives similar results to taking a lower dose every day without food. This approach may help manage side effects while keeping the treatment effective.

Cabozantinib

What is already known about the treatment

Cabozantinib – Cabozantinib is an oral medication taken by mouth that is used to treat kidney cancer (renal cell carcinoma). It works by blocking specific proteins called tyrosine kinases that help cancer cells grow and form new blood vessels, essentially cutting off the tumor's blood supply and slowing its growth. This medication belongs to a class of drugs known as targeted cancer therapies or tyrosine kinase inhibitors. In this clinical trial, researchers are studying whether taking a higher dose of cabozantinib with food but skipping certain days might work as well as taking a lower daily dose without food, which could help patients manage side effects better.

Investigated diseases

Renal Cell Carcinoma – Renal cell carcinoma is a type of cancer that develops in the kidneys, specifically in the lining of the small tubes within the kidney that filter blood and produce urine. It is the most common form of kidney cancer in adults. The disease typically begins as a single tumor in one kidney, but in some cases it can affect both kidneys or appear as multiple tumors. As the cancer grows, it may spread beyond the kidney to nearby tissues and organs. In more advanced stages, the cancer cells can travel through the bloodstream or lymphatic system to other parts of the body, such as the lungs, bones, or liver. Early stages of renal cell carcinoma often produce no noticeable symptoms, but as it progresses, patients may experience blood in the urine, back pain, a lump in the abdomen, fatigue, and unexplained weight loss.