Taking cabozantinib on a skip-days schedule instead of lowering the daily dose

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with metastatic renal cell carcinoma who are stable on 20 mg or 40 mg daily cabozantinib will follow either the standard daily dosing or an experimental skip-days schedule for four weeks. The experimental schedules use 60 mg on one or two days followed by one or two days off (60-0-0 or 60-60-0), while standard dosing remains 20 mg or 40 mg once daily with a standard breakfast. Blood samples collected after four weeks and at 1 and 3 days post-visit will be used to compare pharmacokinetic exposure, and patients will complete questionnaires about side effects and quality of life. The study aims to determine whether similar drug exposure can be achieved with fewer tablets while monitoring tolerability and patient-reported outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lumc
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Tom van der Hulle, MD PhD — Leiden University Medical Center
• Study coordinator: Tom van der Hulle, MD PhD
• Email: t.van_der_hulle@lumc.nl
• Phone: 0031715263464

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.