Trial reportCancer chemotherapy and pharmacology2012
The effect of food on the bioavailability of panobinostat, an orally active pan-histone deacetylase inhibitor, in patients with advanced cancer.
Trial report in Cancer chemotherapy and pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed.
- Effect of Food on the Pharmacokinetics of Saroglitazar Magnesium, a Novel Dual PPARαγ Agonist, in Healthy Adult Subjects.Clinical drug investigation · 2018Trial
- Panobinostat PK/PD profile in combination with bortezomib and dexamethasone in patients with relapsed and relapsed/refractory multiple myeloma.European journal of clinical pharmacology · 2016Trial
- Population pharmacokinetics of intravenous and oral panobinostat in patients with hematologic and solid tumors.European journal of clinical pharmacology · 2015Trial
- Conflicting meal recommendations for oral oncology drugs: pose risks to patient care?European journal of clinical pharmacology · 2018Article
- Clinical Pharmacokinetics and Pharmacodynamics of Panobinostat.Clinical pharmacokinetics · 2018Review
- Histone Deacetylase Inhibitors Enhance CD4 T Cell Susceptibility to NK Cell Killing but Reduce NK Cell Function.PLoS pathogens · 2016Article
- Functional and Transcriptional Characterization of Histone Deacetylase Inhibitor-Mediated Cardiac Adverse Effects in Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes.Stem cells translational medicine · 2016Article
- Panobinostat as Pan-deacetylase Inhibitor for the Treatment of Pancreatic Cancer: Recent Progress and Future Prospects.Oncology and therapy · 2016Review
- Role of Histone Deacetylase Inhibitors in Relapsed Refractory Multiple Myeloma: A Focus on Vorinostat and Panobinostat.Pharmacotherapy · 2015Review
- Panobinostat: first global approval.Drugs · 2015Review
- Epigenetic treatment of solid tumours: a review of clinical trials.Clinical epigenetics · 2015Review
- Histone deacetylase inhibitors impair the elimination of HIV-infected cells by cytotoxic T-lymphocytes.PLoS pathogens · 2014Article
- Phase I trial of carboplatin and etoposide in combination with panobinostat in patients with lung cancer.Anticancer research · 2013Article
- Sustained inhibition of deacetylases is required for the antitumor activity of the histone deactylase inhibitors panobinostat and vorinostat in models of colorectal cancer.Investigational new drugs · 2013Article
- A proposal regarding reporting of in vitro testing results.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Article
- Profile of panobinostat and its potential for treatment in solid tumors: an update.OncoTargets and therapy · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
purposePanobinostat is a novel oral pan-deacetylase inhibitor with promising anti-cancer activity. The study aimed to determine the influence of food on the oral bioavailability of panobinostat.
methodsThis multicenter study consisted of a randomized, three-way crossover, food-effect study period (cycle 1) followed by single-agent panobinostat continual treatment phase in patients with advanced cancer. Patients received panobinostat 20 mg twice weekly, and panobinostat pharmacokinetics was investigated on days 1, 8, and 15 with a randomly assigned sequence of three prandial states (fasting, high-fat, and normal breakfast).
resultsThirty-six patients were assessed for the food effect on pharmacokinetics and safety in cycle 1, after which 29 patients continued treatment, receiving single-agent panobinostat. Safety and antitumor activity were assessed during the extension period. Panobinostat systemic exposure was marginally reduced (14-16%) following food [geometric mean ratio (GMR) of the AUC(0-∞)/high-fat breakfast/fasting, 0.84 (90% confidence interval {CI}, 0.74-0.96); normal breakfast/fasting, 0.86 (90% CI, 0.75-1.00)], and interpatient variability (coefficient of variation, 59%) remained essentially unchanged with or without food. Panobinostat C (max) was reduced by 44% (high-fat) and 36% (normal) with median T (max) prolonged by 1-1.5 h following food. Panobinostat was well tolerated, with thrombocytopenia, fatigue, nausea, and vomiting as common adverse events, and demonstrated antitumor activity with one patient with a partial response and six patients with stable disease as best response.
conclusionsFood produced minor changes in oral panobinostat exposure; thus, panobinostat can be given without regard to food intake in future clinical studies.
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