Pharmacokinetics, metabolism, and excretion of 14C-labeled belinostat in patients with recurrent or progressive malignancies View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2016-04

AUTHORS

Emiliano Calvo, Guru Reddy, Valentina Boni, Lina García-Cañamaque, Tao Song, Jette Tjornelund, Mi Rim Choi, Lee F. Allen

ABSTRACT

BACKGROUND: Belinostat, a potent pan-inhibitor of histone deacetylase (HDAC) enzymes, is approved in the United States (US) for relapsed/refractory peripheral T-cell lymphoma. In nonclinical studies, bile and feces were identified as the predominant elimination routes (50-70%), with renal excretion accounting for ~30-50%. A Phase 1 human mass balance study was conducted to identify species-dependent variations in belinostat metabolism and elimination. METHODS: Patients received a single 30-min intravenous (i.v.) infusion of (14)C-labeled belinostat (1500 mg). Venous blood samples and pooled urine and fecal samples were evaluated using liquid chromatography-tandem mass spectroscopy for belinostat and metabolite concentrations pre-infusion through 7 days post-infusion. Total radioactivity was determined using liquid scintillation counting. Continued treatment with nonradiolabled belinostat (1000 mg/m(2) on Days 1-5 every 21 days) was permitted. RESULTS: Belinostat was extensively metabolized and mostly cleared from plasma within 8 h (N = 6), indicating that metabolism is the primary route of elimination. Systemic exposure for the 5 major metabolites was >20% of parent, with belinostat glucuronide the predominant metabolite. Mean recovery of radioactive belinostat was 94.5% ± 4.0%, with the majority excreted within 48 and 96 h in urine and feces, respectively. Renal elimination was the principal excretion route (mean 84.8% ± 9.8% of total dose); fecal excretion accounted for 9.7% ± 6.5%. Belinostat was well tolerated, with mostly mild to moderate adverse events and no treatment-related severe/serious events. CONCLUSION: Mass balance was achieved (~95% mean recovery), with metabolism identified as the primary route of elimination. Radioactivity was predominantly excreted renally as belinostat metabolites. More... »

PAGES

193-201

References to SciGraph publications

  • 2006-01. Mass Balance Studies, with a Focus on Anticancer Drugs in CLINICAL PHARMACOKINETICS
  • 2006-09. Anticancer activities of histone deacetylase inhibitors in NATURE REVIEWS DRUG DISCOVERY
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    http://scigraph.springernature.com/pub.10.1007/s10637-015-0321-8

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    http://dx.doi.org/10.1007/s10637-015-0321-8

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1000181574

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/26769244


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