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Breakfast breakthrough? study tests if food can improve kidney cancer drug tolerability

NCT ID NCT05263245

Disease control Sponsor: dr. Tom van der Hulle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether taking the kidney cancer drug cabozantinib with a light breakfast changes how much drug gets into the body. Twelve patients with advanced kidney cancer took the drug both on an empty stomach and with a light breakfast, and researchers measured drug levels in their blood. The goal is to see if eating a light breakfast could allow patients to skip doses occasionally, potentially reducing side effects and costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabozantinib
What this could lead to
If it works, this could lead to a more convenient dosing schedule for cabozantinib, potentially reducing side effects and treatment costs.
What could go wrong
This is a small, early-phase study with only 12 participants, so results may not apply broadly. The main goal is measuring drug levels, not proving better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

12 people

The number who actually took part.

Started

May 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing and able to provide informed consent; * Aged 18 years or older; * Histologically confirmed advanced renal cell carcinoma; * Receiving cabozantinib as monotherapy as treatment for RCC; * At least 4 weeks on a stable dosage of cabozantinib; * 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; * Cabozantinib trough concentration ≤1125 ng/ml in steady state Exclusion Criteria: * Inability to follow the recommended light breakfast; * Gastro-intestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel diseases, malabsorption syndrome and prior major surgery of the stomach, pancreas, liver or smaller bowel. * Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grape fruit juice, clarithromycin, erythromycin, itraconazole and ritonavir. * Use of moderate or strong inducer of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including rifampicin, phenytoin, carbamazepine, phenobarbital and herbal preparations containing St. John's Wort. * Use of inhibitor of multidrug resistance-associated protein 2 within 1 month of start of treatment with cabozantinib, including cyclosporine, delavirdine, efavirenz, emtricitabine, benzbromarone and probenecid.

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Conditions

The condition(s) this trial relates to.

carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA, Netherlands

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