Effects of Cabozantinib Taken with a Light Breakfast

The Pharmacological Effects of Using Cabozantinib With a Light Breakfast: the Skippy 1 Study

This study is testing if taking cabozantinib with a light breakfast instead of on an empty stomach can help people with advanced kidney cancer feel better and absorb the medication more effectively.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Drugs / interventions: cabozantinib
• Locations: 2 sites (Leiden, Zuid-Holland and 1 other locations)
• Trial ID: NCT05263245 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced renal cell carcinoma who are currently stable on cabozantinib.

Not a fit: Patients with gastrointestinal abnormalities affecting drug absorption or those unable to follow the light breakfast protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the tolerability of cabozantinib, potentially improving patient adherence and outcomes.

How similar studies have performed: While the specific approach of taking cabozantinib with food is novel, similar studies on food-drug interactions have shown promising results in improving drug efficacy and reducing side effects.

Eligibility criteria

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 this trial is running

Leiden, Zuid-Holland and 1 other locations

• 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

Conditions Renal Cell Carcinoma; Carcinoma, Renal Cell / drug therapy; Cabozantinib; Angiogenesis Inhibitors / pharmacokinetics; Food-drug interactions