Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009
Effects of food on the relative bioavailability of lapatinib in cancer patients.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 138 citations in OpenAlex.
- Effect of High-Fat Food on the Pharmacokinetic Profile and Safety of SAF-189s, an ALK/ROS1 Inhibitor, in Healthy Chinese Adults.Drugs in R&D · 2023Trial
- Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial.Cancer medicine · 2020Trial
- Administration of Lapatinib with Food Increases Its Plasma Concentration in Chinese Patients with Metastatic Breast Cancer: A Prospective Phase II Study.The oncologist · 2020Trial
- Effect of Food on the Pharmacokinetics of Quizartinib.Clinical pharmacology in drug development · 2020Trial
- Randomized, Open-Label, Crossover Studies Evaluating the Effect of Food and Liquid Formulation on the Pharmacokinetics of the Novel Focal Adhesion Kinase (FAK) Inhibitor BI 853520.Targeted oncology · 2019Trial
- The Effect of a High-Fat Meal on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor, in Patients With Advanced Solid Tumors or Lymphoma.Journal of clinical pharmacology · 2016Trial
- Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes.Leukemia · 2016Trial
- Effects of low-fat and high-fat meals on steady-state pharmacokinetics of lapatinib in patients with advanced solid tumours.Investigational new drugs · 2014Trial
- Phase I study evaluating the combination of lapatinib (a Her2/Neu and EGFR inhibitor) and everolimus (an mTOR inhibitor) in patients with advanced cancers: South West Oncology Group (SWOG) Study S0528.Cancer chemotherapy and pharmacology · 2013Trial
- Food Effects, Pharmacokinetic Drug-Drug Interactions, and Clinical Optimization of Oral Anticancer Agents.Pharmaceutics · 2026Review
- Reducing the Burden of Interaction Studies in Cancer Patients Using a Stable Isotopically Labeled Microtracer: A Proof-of-Concept Study with Alectinib.Clinical pharmacology and therapeutics · 2026Article
- Food-drug interactions: Modelling knowledge and attitude among healthcare professionals at the Ho Teaching Hospital.PloS one · 2025Article
- Optimising oncology drug expenditure in Ireland.Irish journal of medical science · 2024Review
- Intermittent fasting and its impact on toxicities, symptoms and quality of life in patients on active cancer treatment.Cancer treatment reviews · 2024Review
- Comparative pharmacokinetics of tyrosine kinase inhibitor, lapatinib, in dogs and cats following single oral administration.The Journal of veterinary medical science · 2024Article
- Her2 positive metastatic breast cancer treated with low dose lapatinib in a resource-constrained setting in South India: a retrospective audit.Ecancermedicalscience · 2024Article
- The use of microtracers in food-effect trials: An alternative study design for toxic drugs with long half-lives exemplified by the case for alectinib.Clinical and translational science · 2023Article
- Dissecting sources of variability in patient response to targeted therapy: anti-HER2 therapies as a case study.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2023Article
- Article
- Short-term fasting and fasting mimicking diets combined with chemotherapy: a narrative review.Therapeutic advances in medical oncology · 2023Review
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
Abstract
purposeThis study was conducted to characterize the effect of food on the relative bioavailability of lapatinib. PATIENTS AND
methodsA single 1,500-mg, oral dose of lapatinib was administered to 27 patients with advanced solid tumors on each of three occasions that were 1 week apart, in random order: after an overnight fast, with a low-fat breakfast, and with a high-fat breakfast.
resultsThe low-fat breakfast produced mean increases in lapatinib area under the concentration-time curve (AUC) of 167% (2.67-fold) and maximum concentration (C(max)) of 142% (2.42-fold). The high-fat breakfast produced mean increases in lapatinib AUC of 325% (4.25-fold) and C(max) of 203% (3.03-fold) compared with the fasted state. Increased bioavailability in the fed state did not significantly decrease relative variability. Therefore, absolute variability in systemic exposure was increased.
conclusionThese large increases in lapatinib bioavailability and absolute variability support the recommendation for dosing in the fasted state to achieve consistent therapeutic exposure. Prescribers and patients should consider the potential consequences of toxicity or diminished efficacy that might result from dosing without regard to variations in diet.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.