The Effect of Taking Cabozantinib with a Light Breakfast:...

연구 요약

The Effect of Taking Cabozantinib with a Light Breakfast: A Randomized Crossover Pharmacokinetic Study (SKIPPY 1).

Clinical pharmacokinetics 학술지에 발표된 이 연구는 Rieborn A, Guchelaar NAD, van Gelder T 외 연구팀이 수행하였습니다.

핵심 내용

BACKGROUND AND OBJECTIVE: Cabozantinib is a tyrosine kinase inhibitor approved for the treatment of metastatic renal cell carcinoma. The current patient-unfriendly advice to ingest cabozantinib in a fasted state is based on an increase of 57% in the area under the concentration-time curve after ingestion with a high-fat meal. Taking cabozantinib with a meal that is suitable for daily practice to increase bioavailability could aid in developing alternative dosing strategies. In this study, we aim to investigate the impact of taking cabozantinib with a light breakfast on exposure and toxicity. METHODS: An open-label, randomized, cross-over, pharmacokinetic evaluation study was performed. In the standard regimen, patients took cabozantinib in a fasted state. In the experimental regimen, patients took cabozantinib with a light breakfast. After 4 weeks, pharmacokinetic samples were obtained for area under the concentration-time curve from 0 to 24 h estimation and patients thereafter switched to the other regimen. Patients were monitored for serious adverse events. RESULTS: Twelve patients completed study procedures. The area under the concentration-time curve for taking cabozantinib in a fasted state and with a light breakfast showed a mean difference of + 8.3% (geometric mean ratio, 90% confidence interval 101-117).

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이 연구는 약물 또는 영양제의 안전한 사용에 관한 과학적 근거를 제공할 수 있습니다. 다만, 개별 연구 결과만으로 일반화하기는 어려우며, 추가적인 연구가 필요할 수 있습니다.

실천 사항

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의사/약사의 전문적 판단을 대체하지 않습니다 (PMID: 41555108)