NCT07077161

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
28mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Sep 2028

First Submitted

Initial submission to the registry

July 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

July 8, 2025

Last Update Submit

January 26, 2026

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Renal Cell CarcinomaRCCCabozantinibpharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of the study at approximately 2 months

Secondary Outcomes (5)

  • Health-economic cost-consequences

    From enrollment to the end of the study at approximately 2 months

  • Patients preference

    From enrollment to the end of the study at 2 months

  • Quality of life score

    From enrollment to the end of the study at approximately 2 months

  • Quality of life score

    From enrollment to the end of the study at approximately 2 months

  • Side effects: nausea and/or diarrhea

    From enrollment to the end of the study at approximately 2 months

Study Arms (1)

Standard regimen

ACTIVE COMPARATOR

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

Drug: Cabozantinib

Interventions

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.

Standard regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38874883RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Tom van der Hulle, MD PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom van der Hulle, MD PhD

CONTACT

0031715263464t.van_der_hulle@lumc.nl

Nikki Kerssemakers, MSc

CONTACT

0031683139525n.kerssemakers@lumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: PK equivalence study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 22, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

NL(1)