Cabozantinib Dose Skipping as an Alternative to Dose Reductions

NCT ID: NCT07077161

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-09-01

Brief 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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard regimen

taking 20mg or 40mg cabozantinib once daily with standard breakfast.

Group Type: ACTIVE_COMPARATOR

Cabozantinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

dr. Tom van der Hulle

OTHER

Sponsor Role: lead

Responsible Party

dr. Tom van der Hulle

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tom van der Hulle, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

LUMC

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Tom van der Hulle, MD PhD

Role: CONTACT

t.van_der_hulle@lumc.nl

0031715263464

Nikki Kerssemakers, MSc

Role: CONTACT

n.kerssemakers@lumc.nl

0031683139525

Facility Contacts

Tom van der Hulle

Role: primary

t.van_der_hulle@lumc.nl

0031715263464

Nikki Kerssemakers

Role: backup

n.kerssemakers@lumc.nl

0031683139525

References

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.

Reference Type: RESULT

PMID: 38874883 (View on PubMed)

Other Identifiers

2025-522962-58-00

Identifier Type: CTIS

Identifier Source: secondary_id

SKIPPY2

Identifier Type: -

Identifier Source: org_study_id