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Xenobiotica
the fate of foreign compounds in biological systems
Volume 48, 2018 - Issue 5
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Clinical Pharmacokinetics and Metabolism

Phase 1 study to investigate the pharmacokinetic properties of dacomitinib in healthy adult Chinese subjects genotyped for CYP2D6

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Pages 459-466 | Received 24 Feb 2017, Accepted 12 Jun 2017, Published online: 18 Aug 2017

References

  • Abdul Razak AR, Soulières D, Laurie SA, et al. (2013). A phase II trial of dacomitinib, an oral pan-human EGF receptor (HER) inhibitor, as first-line treatment in recurrent and/or metastatic squamous-cell carcinoma of the head and neck. Ann Oncol 24:761–9
  • Barter ZE, Tucker GT, Rowland-Yeo K. (2013). Differences in cytochrome p450-mediated pharmacokinetics between Chinese and Caucasian populations predicted by mechanistic physiologically based pharmacokinetic modelling. Clin Pharmacokinet 52:1085–100
  • Bello CL, Labadie RR, Ni G, et al. (2012). The effect of dacomitinib (PF-00299804) on CYP2D6 activity in healthy volunteers who are extensive or intermediate metabolizers. Cancer Chemother Pharmacol 69:991–7
  • Bello CL, Smith E, Ruiz-Garcia A, et al. (2013). A phase I, open-label, mass balance study of [(14)C] dacomitinib (PF-00299804) in healthy male volunteers. Cancer Chemother Pharmacol 72:379–85
  • Del Re M, Citi V, Crucitta S, et al. (2016). Pharmacogenetics of CYP2D6 and tamoxifen therapy: light at the end of the tunnel? Pharmacol Res 107:398–406
  • Engelman JA, Zejnullahu K, Gale CM, et al. (2007). PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib. Cancer Res 67:11924–32
  • European Medicines Agency. (1998). ICH Topic E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data [online]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002842.pdf [last accessed 3 Jun 2016]
  • Giri N, Masters JC, Plotka A, et al. (2015). Investigation of the impact of hepatic impairment on the pharmacokinetics of dacomitinib. Invest New Drugs 33:931–41
  • Gonzales AJ, Hook KE, Althaus IW, et al. (2008). Antitumor activity and pharmacokinetic properties of PF-00299804, a second-generation irreversible pan-erbB receptor tyrosine kinase inhibitor. Mol Cancer Ther 7:1880–9
  • Janne PA, Boss DS, Camidge DR, et al. (2011). Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res 17:1131–9
  • Malinowski HJ, Westelinck A, Sato J, et al. (2008). Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan. J Clin Pharmacol 48:900–8
  • Ramalingam SS, Blackhall F, Krzakowski M, et al. (2012). Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 30:3337–44
  • Ruiz-Garcia A, Giri N, Labadie RR, et al. (2014). A phase I open-label study to investigate the potential drug-drug interaction between single-dose dacomitinib and steady-state paroxetine in healthy volunteers. J Clin Pharmacol 54:555–62
  • Takahashi T, Boku N, Murakami H, et al. (2012). Phase I and pharmacokinetic study of dacomitinib (PF-00299804), an oral irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases, in Japanese patients with advanced solid tumors. Invest New Drugs 30:2352–63

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