Renal Cell Carcinoma (RCC)Phase 2SKIPPY 2NCT07077161
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
A Phase 2 study testing Cabozantinib in people with Renal Cell Carcinoma (RCC), run by dr. Tom van der Hulle at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jan 2026to 1 Sep 2028
- Phase
- Phase 2
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;
- At least 4 weeks on a stable dosage of cabozantinib of 40 mg or 20 mg once daily as single-agent treatment or in combination with nivolumab;
- 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.
Who cannot join
- Inability to follow the recommended standard breakfast;
- Gastrointestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel disease, malabsorption syndrome, and prior major surgery of the stomach, pancreas, liver or small bowel.
- Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grapefruit 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
LUMC
Leiden, South Holland, 2333ZA
Tom van der Hulle, 0031715263464, t.van_der_hulle@lumc.nl
Nikki Kerssemakers, 0031683139525, n.kerssemakers@lumc.nl
About this study
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:
Read more
- 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.
Read the detailed description
Standard regimens: 20 or 40mg once daily with standard breakfast
Experimental regimens:
- Instead of 20mg once daily: 60mg for one day, followed by two skipping days (60-0-0). Also taken with standard breakfast.
- Instead of 40mg once daily: 60mg for two days, followed by one skipping day (60-60-0). Also taken with standard breakfast.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Cabozantinib
- Keywords
- Renal Cell Carcinoma, RCC, Cabozantinib, pharmacokinetics
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
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 group | Role | What they receive |
|---|---|---|
| Standard regimen | Active comparator | taking 20mg or 40mg cabozantinib once daily with standard breakfast. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the AUC0-72h of the experimental and the standard regimen.
AUC is calculated by modeliing a PK curve from plasma concentrations. AUCs are compared between the standard and experimental regimen.
Measured: From enrollment to the end of the study at approximately 2 months
Comparison of blood trough concentration (Ctrough)
Comparison of Ctrough, which is the plasma concentration of cabozantinib before ingestion of a dose cabozantinib, between the standard and experimental regimen.
Measured: From enrollment to the end of the study at approximately 2 months
Secondary outcomes (5)
Health-economic cost-consequences
Calculating the cost-savings of the alternative dosing regimens
Measured: From enrollment to the end of the study at approximately 2 months
Patients preference
Patients preference of one of the dosing regimens.
Measured: From enrollment to the end of the study at 2 months
Quality of life score
Fill in a questionnaires (EQ-5D-5L) about the quality of life. Which looks into two things:
- Five dimensions of health: mobility, self-care, daily activities, pain/disconfomrt and anxiety/some feelings. It uses a five point scale with 1 equally to no problem and 5 equally to extreme problems. It results in a score with 0 equally to dead and 1 equally to perfect health.
- Subjective assessment of one's own health on a scale from 0 to 100. Where 0 equals worst imaginable health and 100 equals best imaginable health.
Measured: From enrollment to the end of the study at approximately 2 months
Quality of life score
Fill in a questionnaire (FKSI-19) with questions reflecting quality of life in patients with RCC. A question is answered using a 5-point scale where zero equals not at all and 4 equals very much. The higher the score the better the quality of life.
Measured: From enrollment to the end of the study at approximately 2 months
Side effects: nausea and/or diarrhea
Total number of patients experiencing nausea and/or diarrhea
Measured: From enrollment to the end of the study at approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start26 Jan 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
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 Carcinoma (RCC)Studies 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
- PK equivalence study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. Tom van der Hulle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Tom van der Hulle, Leiden University Medical Center
- Investigators
- Tom van der Hulle, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077161
- Sponsor's protocol ID
- SKIPPY2
- Other IDs
- 2025-522962-58-00, 2025
- Acronym
- SKIPPY 2
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2025
- Last updated
- 31 Aug 2026
- 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
Tan Z, Voller S, Yin A, Rieborn A, Gelderblom AJ, van der Hulle T, Knibbe CAJ, Moes DJAR. Population Pharmacokinetics of Cabozantinib in Metastatic Renal Cell Carcinoma Patients: Towards Drug Expenses Saving Regimens. Clin Pharmacokinet. 2024 Jun;63(6):857-869. doi: 10.1007/s40262-024-01379-y. Epub 2024 Jun 14.
PubMed 38874883