Renal Cell CarcinomaPhase 2Skippy 1NCT05263245

The Pharmacological Effects of Using Cabozantinib With a Light Breakfast

A Phase 2 study testing Light breakfast in people with Renal Cell Carcinoma, run by dr. Tom van der Hulle at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Carcinoma
What is being tested?: Light breakfast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesNetherlands
Study dates: 25 May 2023to 11 Mar 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

Official title: The Pharmacological Effects of Using Cabozantinib With a Light Breakfast: the Skippy 1 Study

Cabozantinib is a drug which is used to treat metastasized kidney cancer. While it works well, it has a lot of side effects and is quite expensive (€213,- every tablet, €6403,- every month). The standard recommended dose is 60 mg once a day, taken in fasted state. This means patients are not allowed to eat at least 2 hours before and one hour after taking cabozantinib. In daily practice, this is difficult for patients. It might be that by taking with breakfast the chance of side effects like nausea and diarrhea decreases. If patients take cabozantinib with breakfast, the body will have a higher uptake of the drug.

Often the dose of cabozantinib has to be lowered due to side effects. All tablets cabozantinib have the same price, despite how many milligrams are in the tablets. Cabozantinib stays in the body for a long time after ingestion. It takes approximately 120 hours before half of the medicine has left the body. This means it might not be necessary to take cabozantinib every day. Therefore, it is interesting to investigate if taking cabozantinib with breakfast makes it possible to skip taking cabozantinib once in a while. In this study, the investigators want to investigate to what extent the exposure of cabozantinib increases after ingestion with a light breakfast. The results from this study will be used for the development of alternative dosing regimens with cabozantinib tablets of 60 mg taken with a light breakfast including skipping days.

In this study, patients will randomized to start with taking cabozantinib in fasted state (standard regimen) and taking cabozantinib with a light breakfast (experimental regimen). Menu options will be provided. After at least 4 weeks taking cabozantinib according to the randomized regimen, patients will be submitted to the hospital for one day to measure the amount of cabozantinib in the blood at several points of time. This will be measured by venepuncture and fingerprick microsampling. When all blood samples have been collected, the patient will switch to the other regimen. After at least 4 weeks taking cabozantinib according to the second regimen, venous blood samples will be collected in exactly the same way. After all patients have completed the study, an analysis will be performed to determine the change in exposure to cabozantinib when it is taken with a light breakfast. The results will be used in order to determine the definitive experimental dosing regimens that will be investigated a subsequent study. Patients will be monitored for side effects, especially nausea and/or diarrhea.

The primary goal is to investigate to what extent the exposure of cabozantinib increases by taking cabozantinib with a light breakfast compared to taking cabozantinib in fasted state. The secondary objective is to investigate the analytical feasibility of microsampling (finger prick) for cabozantinib concentration measurements and to monitor side effects.

Conditions: Renal Cell Carcinoma
Being tested: Light breakfast
Keywords: Carcinoma, Renal Cell / drug therapy, Cabozantinib, Angiogenesis Inhibitors / pharmacokinetics, Food-drug interactions
Medical subject headings: Carcinoma, Renal Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Light breakfastOther
Light breakfast, standardized by 7 menu options for patients. All breakfast options contain the same amount of fat (9-10 g). Example of a menu: 150 ml full-fat yoghurt, 40 gram muesli with sugar, 1 glass of tea.

Study groups in NCT05263245
Study group	Role	What they receive
Standard regimen	No intervention	Patients will continue to use cabozantinib in fasted state, as part of standard of care, in the recommended dose as prior to enrollment in the study.
Experimental regimen	Experimental	Patients will take the prior recommended dose cabozantinib with a light breakfast. Receives: Other: Light breakfast

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the concentration-time curve (AUC)
Increase of the area under the concentration-time curve (AUC) of the experimental regimen compared to the standard regimen
Measured: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4, 5, 6, 8 and 24 hours)

Secondary outcomes (2)

Analytical feasibility
Analytical correlation/agreement between venapuncture (plasma) measurements and microsampling (whole blood and capillary plasma) measurements
Measured: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4)
Adverse events
The total number of patients experiencing (S)AEs
Measured: At inclusion and at both hospital admissions after at least 28 days on the regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 202311 Mar 2025

First posted2 Mar 2022
Study start25 May 2023
Primary completion11 Mar 2025
Study completion11 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Multicenter open label randomized cross-over design. Patients will be randomized to start with the experimental or standard regimen. In the experimental regimen, patients will take cabozantinib with a light breakfast. In the standard regimen, patients will take cabozantinib in fasted state. After all pharmacokinetic samples have been completed, patients will switch to the other regimen.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05263245
Sponsor's protocol ID: 81846
Acronym: Skippy 1
Status last verified: Sep 2025
First submitted: 11 Feb 2022
Last updated: 3 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: To be determined in detail

Publications

Rieborn A, Guchelaar NAD, van Gelder T, Gelderblom H, Luelmo SAC, Kerssemakers N, Hamberg PAP, Koolen SLW, Mathijssen RHJ, Moes DJAR, van der Hulle T. The Effect of Taking Cabozantinib with a Light Breakfast: A Randomized Crossover Pharmacokinetic Study (SKIPPY 1). Clin Pharmacokinet. 2026 Mar;65(3):431-439. doi: 10.1007/s40262-025-01612-2. Epub 2026 Jan 19.
PubMed 41555108

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Pharmacological Effects of Using Cabozantinib With a Light Breakfast: the Skippy 1 Study
ClinicalTrials.gov ID: NCT05263245
Acronym / sponsor ID: Skippy 1 / 81846
Conditions: Renal Cell Carcinoma
Keywords: Carcinoma, Renal Cell / drug therapy, Cabozantinib, Angiogenesis Inhibitors / pharmacokinetics, Food-drug interactions
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: dr. Tom van der HulleUniversity, hospital or other
Collaborators: Leiden University Medical Center
Study start: 25 May 2023 (actual)
Primary completion: 11 Mar 2025 (actual)
Study completion: 11 Mar 2025 (actual)
First posted: 2 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Multicenter open label randomized cross-over design. Patients will be randomized to start with the experimental or standard regimen. In the experimental regimen, patients will take cabozantinib with a light breakfast. In the standard regimen, patients will take cabozantinib in fasted state. After all pharmacokinetic samples have been completed, patients will switch to the other regimen.

Arm	Type	Receives
Standard regimen	No intervention	–Patients will continue to use cabozantinib in fasted state, as part of standard of care, in the recommended dose as prior to enrollment in the study.
Experimental regimen	Experimental	Other: Light breakfastPatients will take the prior recommended dose cabozantinib with a light breakfast.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Light breakfastLight breakfast, standardized by 7 menu options for patients. All breakfast options contain the same amount of fat (9-10 g). Example of a menu: 150 ml full-fat yoghurt, 40 gram muesli with sugar, 1 glass of tea.	Other	Experimental regimen

Primary outcome

Area under the concentration-time curve (AUC)
Time frame: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4, 5, 6, 8 and 24 hours)
Increase of the area under the concentration-time curve (AUC) of the experimental regimen compared to the standard regimen

2 secondary outcomes

Analytical feasibility
Time frame: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4)
Adverse events
Time frame: At inclusion and at both hospital admissions after at least 28 days on the regimen

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Derived from this study: PubMed 41555108Rieborn A, Guchelaar NAD, van Gelder T, Gelderblom H, Luelmo SAC, Kerssemakers N, Hamberg PAP, Koolen SLW, Mathijssen RHJ, Moes DJAR, van der Hulle T. The Effect of Taking Cabozantinib with a Light Breakfast: A Randomized Crossover Pharmacokinetic Study (SKIPPY 1). Clin Pharmacokinet. 2026 Mar;65(3):431-439. doi: 10.1007/s40262-025-01612-2. Epub 2026 Jan 19.
Individual participant dataSharing planned: Undecided. To be determined in detail

Related trials for Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tom van der Hulle, MD PhD principal investigator

Leiden University Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Light breakfast in people with Renal Cell Carcinoma, run by dr. Tom van der Hulle at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve (AUC) (time frame: At both hospital admissions after at least 28 days on the regimen (t = 0, 1, 2, 3, 4, 5, 6, 8 and 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.