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Original Research

Metabolic Stability Assessment of Larotrectinib Using Liquid Chromatography Tandem Mass Spectrometry

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Pages 111-119 | Published online: 10 Jan 2020

References

  • DoebeleRC, DavisLE, VaishnaviA, et al. An oncogenic NTRK fusion in a patient with soft-tissue sarcoma with response to the tropomyosin-related kinase inhibitor LOXO-101. Cancer Discov. 2015;5(10):1049–1057. doi:10.1158/2159-8290.CD-15-044326216294
  • AmatuA, Sartore-BianchiA, SienaS. NTRK gene fusions as novel targets of cancer therapy across multiple tumour types. ESMO Open. 2016;1(2):e000023. doi:10.1136/esmoopen-2015-00002327843590
  • DrilonA, LaetschTW, KummarS, et al. Efficacy of larotrectinib in TRK fusion–positive cancers in adults and children. N Engl J Med. 2018;378(8):731–739. doi:10.1056/NEJMoa171444829466156
  • KummarS, LassenUN. TRK inhibition: a new tumor-agnostic treatment strategy. Target Oncol. 2018;13(5):545–556. doi:10.1007/s11523-018-0590-130276762
  • LaetschTW, HawkinsDS. Larotrectinib for the treatment of TRK fusion solid tumors. Expert Rev Anticancer Ther. 2019;19(1):1–10. doi:10.1080/14737140.2019.153879630350734
  • A key Genetic ODT. Recent FDa news advancing treatments in oncology. Oncology Times. 2019.
  • BergerS, MartensUM, BochumS. Larotrectinib (LOXO-101) Recent Results Cancer Res; 2018:141–151.
  • SparidansRW, WangY, SchinkelAH, SchellensJH, BeijnenJH. Quantitative bioanalytical assay for the tropomyosin receptor kinase inhibitor larotrectinib in mouse plasma and tissue homogenates using liquid chromatography-tandem mass spectrometry. J Chromatogr B. 2018;1102:167–172. doi:10.1016/j.jchromb.2018.10.023
  • SchellingerAP, CarrPW. Isocratic and gradient elution chromatography: a comparison in terms of speed, retention reproducibility and quantitation. J Chromatogr A. 2006;1109(2):253–266. doi:10.1016/j.chroma.2006.01.04716460742
  • RowlandM, BenetLZ, GrahamGG. Clearance concepts in pharmacokinetics. J Pharmacokinet Biopharm. 1973;1(2):123–136. doi:10.1007/BF010596264764426
  • WilkinsonGR, ShandDG. Commentary: a physiological approach to hepatic drug clearance. Clin Pharmacol Ther. 1975;18(4):377–390. doi:10.1002/cpt.1975.18.issue-41164821
  • HoustonJB. Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol. 1994;47(9):1469–1479. doi:10.1016/0006-2952(94)90520-78185657
  • ObachRS, BaxterJG, ListonTE, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther. 1997;283(1):46–58.9336307
  • BaranczewskiP, StanczakA, SundbergK, et al. Introduction to in vitro estimation of metabolic stability and drug interactions of new chemical entities in drug discovery and development. Pharmacol Rep. 2006;58(4):453–472.16963792
  • DarwishHW, AttwaMW, KadiAA. Rapid validated liquid chromatographic method coupled with Tandem mass spectrometry for quantification of nintedanib in human plasma. Trop J Pharm Res. 2016;15(11):2467–2473. doi:10.4314/tjpr.v15i11.23
  • DarwishHW, KadiAA, AttwaMW, AlmutairiHS. Investigation of metabolic stability of the novel ALK inhibitor brigatinib by liquid chromatography tandem mass spectrometry. Clin Chim Acta. 2018;480:180–185. doi:10.1016/j.cca.2018.02.01629458050
  • AttwaMW, KadiAA, DarwishHW, AmerSM, AlrabiahH. A reliable and stable method for the determination of foretinib in human plasma by LC-MS/MS: application to metabolic stability investigation and excretion rate. Eur J Mass Spectrom. 2018;24(4):344–351. doi:10.1177/1469066718768327
  • AmerSM, KadiAA, DarwishHW, AttwaMW. Liquid chromatography tandem mass spectrometry method for the quantification of vandetanib in human plasma and rat liver microsomes matrices: metabolic stability investigation. Chem Cent J. 2017;11(1):45. doi:10.1186/s13065-017-0274-429086823
  • KadiAA, AbdelhameedAS, DarwishHW, AttwaMW, Al‐ShakliahNS. A highly efficient and sensitive LC‐MS/MS method for the determination of afatinib in human plasma: application to a metabolic stability study. Biomed Chromatogr. 2016;30(8):1248–1255. doi:10.1002/bmc.367426683307
  • AttwaMW, KadiAA, AbdelhameedAS. Reactive intermediates and bioactivation pathways characterization of avitinib by LC–MS/MS: in vitro metabolic investigation. J Pharm Biomed Anal. 2019;164:659–667. doi:10.1016/j.jpba.2018.11.03330472584
  • AttwaMW, KadiAA, DarwishHW, AmerSM, Al-ShakliahNS. Identification and characterization of in vivo, in vitro and reactive metabolites of vandetanib using LC-ESI-MS/MS. Chem Cent J. 2018;12(1):99. doi:10.1186/s13065-018-0467-530251155
  • AbdelhameedAS, AttwaMW, KadiAA. An LC–MS/MS method for rapid and sensitive high‐throughput simultaneous determination of various protein kinase inhibitors in human plasma. Biomed Chromatogr. 2017;31(2):e3793. doi:10.1002/bmc.v31.2
  • ManzoA, MontaninoA, CostanzoR, et al. Chapter 33 - EGFR mutations: best results from second- and third-generation tyrosine kinase inhibitors In: DammaccoF, SilvestrisF, editors. Oncogenomics. Academic Press; 2019:477–486.
  • Health UDo, Services H. Bioanalytical method validation, guidance for industry. 2001 Available from: http://www.fda.gov/cder/guidance/4252fnl.htm. Accessed 102, 2019.
  • KadianN, RajuKSR, RashidM, MalikMY, TanejaI, WahajuddinM. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry. J Pharm Biomed Anal. 2016;126:83–97. doi:10.1016/j.jpba.2016.03.05227179186
  • ScottWJ, HentemannMF, RowleyRB, et al. Discovery and SAR of Novel 2,3-Dihydroimidazo[1,2-c]quinazoline PI3K Inhibitors: identification of Copanlisib (BAY 80-6946). ChemMedChem. 2016;11(14):1517–1530. doi:10.1002/cmdc.20160014827310202
  • Attwa MohamedW, KadiAA, DarwishHW, AbdelhameedAS. Investigation of the metabolic stability of olmutinib by validated LC-MS/MS: quantification in human plasma. RSC Adv. 2018;8(70):40387–40394. doi:10.1039/C8RA08161A
  • KadiAA, DarwishHW, AttwaMW, AmerSM. Validated LC-MS/MS method for the quantification of ponatinib in plasma: application to metabolic stability. PLoS One. 2016;11(10):e0164967. doi:10.1371/journal.pone.016496727764191
  • LeahyDE. Integrating in vitro ADMET data through generic physiologically based pharmacokinetic models. Expert Opin Drug Metab Toxicol. 2006;2(4):619–628. doi:10.1517/17425255.2.4.61916859409