Population pharmacokinetic (PK) analysis of laromustine, an emerging alkylating agent, in cancer patients

References

• Abdelhameed M. (2008). Pharmacokinetics of cloretazine (VNP40101M) and its metabolite VNP4090CE in human plasma samples from clinical study CLI-043. Vion Report CLI-043b (Covance Report 7660-122)
   Google Scholar
• Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–5
   PubMed Web of Science ®Google Scholar
• Finch RA, Shyam K, Penketh PG, Sartorelli AC. (2001). 1,2-Bis(methylsulfonyl)-1-(2-chloroethyl)-2-(methylamino)carbonylhydrazine (101M): a novel sulfonylhydrazine prodrug with broad-spectrum antineoplastic activity. Cancer Res 61:3033–8
   PubMed Web of Science ®Google Scholar
• Gelman A, Bios A, Jiang J. (1996). Physiological pharmacokinetic analysis using population modelling and informative prior distribution. J Am Stat Assoc 91:1400–12
   Web of Science ®Google Scholar
• Guidance for Industry. (1999). Population pharmacokinetics. U.S. Food and Drug Administration
   Google Scholar
• Guideline on reporting. (2007). The results of the population pharmacokinetic analyses. European Medicines Agency
   Google Scholar
• Jiang X. (2008). Pharmacokinetic report for a phase II study of VNP40101M for patients with acute myelogenous leukemia or high-risk myelodysplasia. Vion Report CLI-033b (Covance Report 7660-123)
   Google Scholar
• Karlsson MO, Sheiner LB. (1993). The importance of modelling inter-occasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 21:735–50
   PubMedGoogle Scholar
• Meister A, Anderson ME. (1983). Glutathione. Annu Rev Biochem 52:711–60
   PubMed Web of Science ®Google Scholar
• Moriarty-Craige SE, Jones DP. (2004). Extracellular thiols and thiol/disulfide redox in metabolism. Annu Rev Nutr 24:481–509
   PubMed Web of Science ®Google Scholar
• Nassar A. (2008a). Pharmacokinetics of VNP40101M and VNP4090CE in cancer patients from Vion Clinical Study CLI-011. Vion Report CLI-011a
   Google Scholar
• Nassar A. (2008b). Pharmacokinetics of VNP40101M and VNP4090CE in cancer patients from Vion Clinical Study CLI-028. Vion Report CLI-028a
   Google Scholar
• Nassar A. (2008c). Pharmacokinetics of VNP40101M and VNP4090CE in cancer patients from Vion Clinical Study CLI-029. Vion Report CLI-029a
   Google Scholar
• Nassar AE, King I, Paris BL, et al (2009). An in vitro evaluation of the victim and perpetrator potential of the anti-cancer agent laromustine (VNP40101M), based on reaction phenotyping and inhibition and induction of cytochrome P450 (CYP) enzymes. Drug Metab Dispos 37:1922–30
   PubMed Web of Science ®Google Scholar
• Nassar AE, Du J, Belcourt M, et al (2010a). Chapter 6, “Biotransformation and metabolite elucidation of xenobiotics”. In: Nassar A-EF, ed. Case study: identification of in vitro metabolite/decomposition products of the novel DNA alkylating agent laromustine. Hoboken, NJ: John Wiley & Sons
   Google Scholar
• Nassar AE, Du J, Belcourt M, et al (2010b). Chapter 5, “Biotransformation and metabolite elucidation of xenobiotics”. In: Nassar A-EF, ed. Case study: the unanticipated loss of N2 from novel DNA alkylating agent laromustine by collision-induced dissociation: novel rearrangements. Hoboken, NJ: John Wiley & Sons
   Google Scholar
• Nassar AE, King I, Du J. (2010c). In vitro profiling and mass balance of the anti-cancer agent laromustine [14C]-VNP40101M by rat, dog, monkey and human liver microsomes. Open Drug Metab J 4:1–9
   Google Scholar
• Nassar AE, King I, Du J. (2011). Characterization of short-lived electrophilic metabolites of the anticancer agent laromustine (VNP40101M). Chem Res Toxicol 24:568–78
   PubMed Web of Science ®Google Scholar
• Nassar AF, Wisnewski A, King I. (2015). Metabolic disposition of the anti-cancer agent [(14)C]laromustine in male rats. Xenobiotica 45:711–21
   PubMed Web of Science ®Google Scholar
• Penketh PG, Shyam K, Sartorelli AC. (1994). Studies on the mechanism of decomposition and structural factors affecting the aqueous stability of 1,2-bis(sulfonyl)-1-alkylhydrazines. J Med Chem 37:2912–7
   PubMed Web of Science ®Google Scholar
• Penketh PG, Shyam K, Sartorelli AC. (2000). Comparison of DNA lesions produced by tumor-inhibitory 1,2-bis(sulfonyl)hydrazines and chloroethylnitrosoureas. Biochem Pharmacol 59:283–91
   PubMed Web of Science ®Google Scholar
• Piotmovsky VR. (2000). Population pharmacodynamic and pharmacokinetic modelling via mixed effects. Curr Opin Drug Discov Dev 3:314–30
   PubMedGoogle Scholar
• Pratviel G, Shyam K, Sartorelli AC. (1989). Cytotoxic and DNA-damaging effects of 1,2-bis(sulfonyl)hydrazines on human cells of the Mer + and Mer − phenotype. Cancer Biochem Biophys 10:365–75
   PubMedGoogle Scholar
• Shyam K, Cosby LA, Sartorelli AC. (1985). Synthesis and evaluation of N,N′-bis(arylsulfonyl)hydrazines as antineoplastic agents. J Med Chem 28:525–7
   PubMed Web of Science ®Google Scholar
• Shyam K, Furubayashi R, Hrubiec RT, et al (1986). 1,2-bis(arylsulfonyl)hydrazines. 2. The influence of arylsulfonyl and aralkylsulfonyl substituents on antitumor and alkylating activity. J Med Chem 29:1323–5
   PubMed Web of Science ®Google Scholar
• Shyam K, Hrubiec RT, Furubayashi R, et al (1987). 1,2-Bis(sulfonyl)hydrazines. 3. Effects of structural modification on antineoplastic activity. J Med Chem 30:2157–61
   PubMed Web of Science ®Google Scholar
• Shyam K, Penketh PG, Divo AA, et al (1993). Synthesis and evaluation of 1-acyl-1,2-bis(methylsulfonyl)-2-(2-chloroethyl)hydrazines as antineoplastic agents. J Med Chem 36:3496–502
   PubMed Web of Science ®Google Scholar
• Shyam K, Penketh PG, Loomis RH, et al (1996). Antitumor 2-(aminocarbonyl)-1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-hydrazines. J Med Chem 39:796–801
   PubMed Web of Science ®Google Scholar
• Yano Y, Beal SL, Sheiner LB. (2001). Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J Pharmacokinet Pharmacodyn 28:171–92
   PubMed Web of Science ®Google Scholar