NCT07077161 Cabozantinib Dose Skipping as an Alternative to Dose Reductions
| NCT ID | NCT07077161 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | dr. Tom van der Hulle |
| Condition | Renal Cell Carcinoma (RCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2026-01-26 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Tom van der Hulle, MD PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT07077161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma (RCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07077161 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07077161 currently recruiting?
Yes, NCT07077161 is actively recruiting participants. Contact the research team at t.van_der_hulle@lumc.nl for enrollment information.
Where is the NCT07077161 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT07077161 clinical trial?
NCT07077161 is sponsored by dr. Tom van der Hulle. The principal investigator is Tom van der Hulle, MD PhD at Leiden University Medical Center. The trial plans to enroll 34 participants.