Trial reportClinical pharmacokinetics2026
The Effect of Taking Cabozantinib with a Light Breakfast: A Randomized Crossover Pharmacokinetic Study (SKIPPY 1).
Trial report in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05263245 (The Pharmacological Effects of Using Cabozantinib With a Light Breakfast), which is not on this map. Not yet cited in PubMed.
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The Pharmacological Effects of Using Cabozantinib With a Light Breakfast: the Skippy 1 Study
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11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveCabozantinib 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.
methodsAn 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.
resultsTwelve 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). Similar results were obtained for trough concentration (mean difference 2.5%, geometric mean ratio, 90% confidence interval 90.7-116.0) and maximum concentration (mean difference 14%, geometric mean ratio, 90% confidence interval 103.7-127.6). No differences in serious adverse events were observed.
conclusionsTaking cabozantinib with a light breakfast leads to a small increase in exposure. Patients for whom taking cabozantinib in a fasted state is unpleasant are now able to take it with a light breakfast, without an increased risk for exposure-related toxicity. CLINICAL
trial registrationThis study was registered at ClinicalTrials.gov under the number NCT05263245.
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