Effects of Cabozantinib Taken with a Light Breakfast

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

This study investigates the pharmacological effects of taking cabozantinib, a drug used to treat advanced renal cell carcinoma, with a light breakfast instead of on an empty stomach. The aim is to determine if this approach can reduce side effects such as nausea and diarrhea while improving drug absorption. Participants will be required to maintain a stable dosage of cabozantinib for at least four weeks prior to the study. The study will assess the tolerability and effectiveness of this modified intake method in patients already receiving cabozantinib as monotherapy.

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;
* Receiving cabozantinib as monotherapy as treatment for RCC;
* At least 4 weeks on a stable dosage of cabozantinib;
* 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;
* Cabozantinib trough concentration ≤1125 ng/ml in steady state

Exclusion Criteria:

* Inability to follow the recommended light breakfast;
* Gastro-intestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel diseases, malabsorption syndrome and prior major surgery of the stomach, pancreas, liver or smaller bowel.
* Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grape fruit 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

• Leids Universitair Medisch Centrum
  Leiden, Zuid-Holland, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, Zuid-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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.