Population pharmacokinetic model for daunorubicin and daunorubicinol coadministered with zosuquidar.3HCI (LY335979)

Cancer Chemotherapy and Pharmacology

Volumn 54, Issue 1, 2004, Pages 39-48

  Callies, Sophie ^a   De Alwis, Dinesh P ^b   Mehta, Atul ^c   Burgess, Michael ^b   Aarons, Leon ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b ELI LILLY AND COMPANY   (United States)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Daunorubicin; Daunorubicinol; LY335979; NONMEM; Pharmacokinetics

Indexed keywords

ANTHRACYCLINE; ANTIEMETIC AGENT; CYTARABINE; DAUNORUBICIN; DAUNORUBICINOL; GLYCOPROTEIN P INHIBITOR; HYDROXYUREA; ZOSUQUIDAR;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; DRUG CLEARANCE; HEMATOLOGIC MALIGNANCY; HUMAN; IC 50; MYELODYSPLASTIC SYNDROME; NEUROTOXICITY; PHASE 1 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; TOXICITY;

EID: 3042766320     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-004-0775-4     Document Type: Article

References (41)

1. Advani R, Fisher GA, Lum BL, Hausdorff J, Halsey J, Litchman M, Sikic BI (2001) A phase I trial of doxorubicin, paclitaxel, and Valspodar (PSC833), a modulator of multidrug resistance. Clin Cancer Res 7:1221-1229
2. Ambukar SV, Dey S, Hrycyna CA, Ramachandra M, Pastan I, Gottesman MM (1999) Biochemical, cellular and pharmacological aspects of the multidrug transporter. Annu Rev Pharmacol Toxicol 39:361-368
3. Biedler JL, Riehm H (1970) Cellular resistance to actinomycin D in Chinese hamster cells in vitro: cross-resistance, radioautographic and cytogenetic studies. Cancer Res 30:1174-1184
4. Boeckmann AJ, Sheiner LB, Beal SL (1994) NONMEM users guide. NONMEM project group, University of California, San Francisco
5. Callies S, de Alwis DP, Wright JG, Sandler A, Burgess M, Aarons L (2003) A population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of a novel MDR modulator, zosuquidar trihydrochloride (LY335979). Cancer Chemother Pharmacol 51:107-118
6. Chico I, Kang MH, Bergan R, Abraham J, Bakke S, Meadows B, Rutt A, Robey R, Choyke P, Merino M, Goldspiel B, Smith T, Steinberg S, Fig WD, Fojo T, Bates S (2001) Phase I study of infusional paclitaxel in combination with the P-glycoprotein antagonist PSC833. J Clin Oncol 19:832-842
7. Dantzig AH, Shepard RL, Cao J, Law KL, Ehlhardt WJ, Baughman TM, Bumol TF, Starling JJ (1996) Reversal of P-glycoprotein-mediated multidrug resistance by a potent cyclopropyldibenzosuberane modulator, LY335979. Cancer Res 56:4171-4179
8. Dantzig AH, Shepard RL, Law KL, Tabas L, Pratt S, Gillespie JS, Binkley SN, Kuhfeld MT, Starling JJ, Wrighton SA (1999) Selectivity of the multidrug resistance modulator, LY335979, for P-glycoprotein and effect on cytochrome P-450 activities. J Pharmacol Exp Ther 290:854-862
9. Dantzig AH, Law KL, Cao J, Starling JJ (2001) Reversal of multidrug resistance by the P-glycoprotein modulator LY335979, from the bench to the clinic. Curr Med Chem 8:39-50
10. Dantzig AH, de Alwis DP, Burgess M (2003) Considerations in the design and development of transport inhibitor as adjuncts to drug therapy. Adv Drug Deliv Rev 55:133-155
11. Ehlhardt WJ, Woodland JM, Baughman TM, Vandenbranden M, Wrighton SA, Kroin JS, Norman BH, Maple SR (1998) Liquid chromatography/nuclear magnetic resonance spectroscopy and liquid chromatography/mass spectrometry identification of novel metabolites of the multidrug resistance modulator LY335979 in rat bile and human liver microsomal incubations. Drug Metab Dispos 26:42-51
12. Ferry D, Price L, Atsmon J, Inbar M, Merimsy O, Telligen O, et al (2001) A phase IIA pharmacokinetic and pharmacodynamic study of the P-glycoprotein inhibitor, XR9576, in patient treated with doxorubicin chemotherapy. Proc Am Assoc Cancer Res 42, p 5160
13. Fogli S, Danesi R, Innocenti F (1999) An improved HPLC method for therapeutic drug monitoring of daunorubicin, idarubicin, doxorubicin, epirubicin and their 13-dihydro metabolites in human plasma. Ther Drug Monit 21:367-375
14. Ford JM, Hait WN (1990) Pharmacology of drugs that alter multidrug resistance in cancer. Pharmacol Rev 42:155-199
15. Galaris D, Rydstrom J (1993) Enzyme induction by daunorubicin in neonatal heart cells in culture. Biochem Biophys Res Commun 110:364-370
16. Gessner T, Preisler HD, Azarnia N, Bolonowska W, Vogler WR, Grunwald H (1987) Plasma levels of daunorubicin metabolites and the outcome of ANLL therapy. Med Oncol Tumor Pharmacother 4:23-31
17. Giaccone G, Linn SC, Welink J, Catimel G, Stieltjes H, van der Vijgh WJF, Ecltink C, Vermorken JB, Pinedo HM (1997) A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors. Clin Cancer Res 3:2005-2015
18. Grochow LB, Ames MM (1998) A clinician's guide to chemotherapy pharmacokinetics and pharmacodynamics, 1st edn. Williams & Wilkins, Baltimore, p 93-122
19. Juliano RL, Ling V (1976) A surface glycoprotein modulating drug permeability in chinese hamster ovary cell mutants. Biochim Biophys Acta 455:152-162
20. Karlsson MO, Sheiner LB (1993) The importance of modeling interoccasion variability in population pharmacokinetic analysis. J Pharmacokinet Biopharm 21:735-750
21. Krishna R, Mayer LD (2000) Multidrug resistance (MDR) in cancer; mechanisms, reversal using modulators of MDR and the role of MDR modulators in influencing the pharmacokinetics of anticancer drugs. Eur J Pharm Sci 11:265-283
22. Maniez-Devos, Baurain R, Lesne M (1986) Doxorubicin and daunorubicin plasmatic, hepatic and renal disposition in the rabbit with or without enterohepatic circulation. J Pharmacol 17:1-13
23. Peck RA, Hewett J, Harding MW, Wang YM, Chaturvedi PR, Bhatnagar A, Zeissman H, Atkins F, Hawkins MJ (2001) Phase I and pharmacokinetic study of the novel MDR1 and MRP1 inhibitor Biricodar administered alone and in combination with doxorubicin. J Clin Oncol 19:3130-3141
24. Rahman A, Goodman A, Foo W, et al (1984) Clinical pharmacology of daunorubicin in phase I patients with solid tumours: development of an analytical methodology for daunorubicin and its metabolites. Semin Oncol 11 [Suppl 3]:36
25. Riggs CE (1984) Clinical pharmacology of daunorubicin in patients with acute leukaemia. Semin Oncol 11 [Suppl 3]:2
26. Robert J, Rigal-Huguet F, Hurteloup P. (1992) Comparative pharmacokinetic study of idarubicin and daunorubicin in leukemia patients. Hematol Oncol 10:111
27. Rowinsky EK, Smith L, Wang YM, Chaturvedi P, Villalona M, Campbell E, Aylesworth C, Eckhardt SG, Hammond L, Kraynak M, Drengler R, Stephenson J Jr, Harding MW, Von Hoff DD (1998) Phase I and pharmacokinetic study of paclitaxel in combination with biricodar, a novel agent that reverses multidrug resistance conferred by over expression of both MDR and MRP. J Clin Oncol 16:2964-2976
28. Rubin EH, de Alwis DP, Pouliquen I, Green L, Marder P, Lin Y, Musanti R, Grospe SL, Smith SL, Toppmeyer DL, Much J, Kane M, Chaudhary A, Jordan C, Burgess M, Slapak CA (2002) A phase I trial of a potent P-glycoprotein inhibitor, zosuquidar.3HCl trihydrochloride (LY335979), administered orally in combination with doxorubicin in patients with advanced malignancies. Clin Cancer Res 8:3710-3717
29. Schott B, Robert J (1989) Comparative activity of anthracycline 13-dihydrometabolites against rat glioblastoma cells in culture. Biochem Pharmacol 38:4069-4074
30. Schuetz EG, Beck WT, Schuetz JD (1996) Modulators and substrates of P-glycoprotein and cytochrome P4503A coordinately up-regulate these proteins in human colon carcinoma cells. Mol Pharmacol 49:311-318
31. Sheiner LB, Steimer JL (2000) Pharmacokinetic/pharmacodynamic modeling in drug development. Annu Rev Pharmacol Toxicol 40:67-95
32. Sikic BI, Fisher G A, Lum BL, Halsey J, Beketic-Oreskovic L, Chen G (1997) Modulation and prevention of multidrug resistance by P-glycoprotein. Cancer Chemother Pharmacol [Suppl] 40:S13-S19
33. Sonneveld P, Marie J, Huisman C (1996) Reversal of multidrug resistance by SDZ-PSC833, combined with VAD (vincristine, doxorubicin, dexamethasone) in refractory multiple myeloma. A phase I study. Leukemia 10:1741-1750
34. Spahn-langguth H, Baktir G, Radschuweit A, Okyar A, Terhaag B, Ader P, Hanafy A, Langguth P (1998) P-Glycoprotein transporters and the gastrointestinal tract: evaluation of the potential in vivo relevance of in vitro data employing talinolol as a model compound. Int J Clin Pharmacol Ther 36:16-24
35. Sparreboom A, Planting AST, Jewell RC, van der Burg ME, van der Gaast A, de Bruijn P, Loos WJ, Nooter K, Chandler LH, Paul EM, Wissel PS, Verweij J (1999) Clinical pharmacokinetics of doxorubicin in combination with GF120918, a potent inhibitor of MDR1 P-glycoprotein. Anticancer Drugs 10:719-728
36. Sun H, Fadiran EO, Jones CD, Lesko L, Huang S-M, Higgins K, Hu C, Machado S, Maldonado S, Williams R, Hossain M, Ette EI (1999) Population pharmacokinetics - a regulatory perspective. Clin Pharmacokinet 37:41-51
37. Troconiz IF, de Alwis DP, Tillmann C, Callies S, Mitchell M, Schaefer HG. (2000) Comparison of manual versus ambulatory blood pressure measurements with pharmacokinetic-pharmacodynamic modelling of antihypertensive compounds: application. Clin Pharmacol Ther 68:18-27
38. Van Telligen O, Kemper M, Beijnen JH (2001) P-glycoprotein inhibition in tumors by PSC833: impact of dose adjustments on the efficacy of doxorubicin chemotherapy. Proc Am Assoc Cancer Res 42:950
39. Van Zuylen L, Sparreboom A, van der Gaast A, van der Burg ME, van Beurden V, Bol CJ, Woestenborghs R, Palmer PA, Verweij J (2000) The orally administered P-glycoprotein inhibitor R101933 does not alter the plasma pharmacokinetics of docetaxel. Clin Cancer Res 6:1365-1371
40. Wacher VJ, Wu CY, Benet LZ (1995) Overlapping substrate specificities and tissue distribution of cytochrome P4503A and P-glycoprotein: implications for drug delivery and activity in cancer chemotherapy. Mol Carcinog 13:129-134
41. Wade JR, Beal SL, Sambol NC (1994) Interaction between structural, statistical and covariates models in population pharmacokinetic analysis. J Pharmacokinet Biopharm 22:165-177