Physiologically based pharmacokinetic models for everolimus and sorafenib in mice

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 5, 2013, Pages 1219-1229

  Pawaskar, Dipti K ^a   Straubinger, Robert M ^a,b   Fetterly, Gerald J ^b   Hylander, Bonnie H ^b   Repasky, Elizabeth A ^b   Ma, Wen W ^b   Jusko, William J ^a  

^a UNIVERSITY AT BUFFALO   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

Everolimus; Pancreatic cancer; Patient derived pancreatic adenocarcinoma; PBPK; Sorafenib

Indexed keywords

EVEROLIMUS; SORAFENIB;

ADIPOSE TISSUE; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG BRAIN LEVEL; DRUG CLEARANCE; DRUG COMPETITION; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG LIVER LEVEL; DRUG MUSCLE LEVEL; DRUG TUMOR LEVEL; GASTROINTESTINAL TRACT; HUMAN; HUMAN TISSUE; KIDNEY; LUNG; MALE; MAXIMUM PLASMA CONCENTRATION; MODEL; MONOTHERAPY; MOUSE; MULTIPLE DRUG DOSE; NONHUMAN; PANCREAS; PANCREAS ADENOCARCINOMA; PRIORITY JOURNAL; SINGLE DRUG DOSE; SPLEEN; TIME TO MAXIMUM PLASMA CONCENTRATION; TISSUE DISTRIBUTION;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ANIMALS; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHROMATOGRAPHY, LIQUID; DRUG INTERACTIONS; MALE; MICE; MICE, INBRED BALB C; MICE, SCID; MODELS, BIOLOGICAL; NIACINAMIDE; PANCREATIC NEOPLASMS; PHENYLUREA COMPOUNDS; SIROLIMUS; TANDEM MASS SPECTROMETRY; TISSUE DISTRIBUTION;

EID: 84877925813     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2116-y     Document Type: Article

References (35)

1. Atkins MB, Yasothan U, Kirkpatrick P (2009) Everolimus. Nat Rev Drug Discov 8:535-536
2. Piguet AC, Saar B, Hlushchuk R, St-Pierre MV, McSheehy PM, Radojevic V, Afthinos M, Terracciano L, Djonov V, Dufour JF (2011) Everolimus augments the effects of sorafenib in a syngeneic orthotopic model of hepatocellular carcinoma. Mol Cancer Ther 10:1007-1017
3. Rubio-Viqueira B, Hidalgo M (2006) Targeting mTOR for cancer treatment. Curr Opin Investig Drugs 7:501-512
4. Agarwal S, Sane R, Ohlfest JR, Elmquist WF (2011) The role of the breast cancer resistance protein (ABCG2) in the distribution of sorafenib to the brain. J Pharmacol Exp Ther 336:223-233
5. Harzstark AL, Small EJ, Weinberg VK, Sun J, Ryan CJ, Lin AM, Fong L, Brocks DR, Rosenberg JE (2011) A phase 1 study of everolimus and sorafenib for metastatic clear cell renal cell carcinoma. Cancer 117:4194-4200
6. McKeage K, Wagstaff AJ (2007) Sorafenib: in advanced renal cancer. Drugs 67:475-483 discussion 484-5
7. (2007) Nexavar Tablet prescribing information
8. Wilhelm S, Chien DS (2002) BAY 43-9006: preclinical data. Curr Pharm Des 8:2255-2257
9. Komar G, Kauhanen S, Liukko K, Seppanen M, Kajander S, Ovaska J, Nuutila P, Minn H (2009) Decreased blood flow with increased metabolic activity: a novel sign of pancreatic tumor aggressiveness. Clin Cancer Res 15:5511-5517
10. Gjedde SB, Gjedde A (1980) Organ blood flow rates and cardiac output of the BALB/c mouse. Comp Biochem Physiol A Physiol 67:5
11. Mager DE, Jusko WJ (2001) Pharmacodynamic modeling of time-dependent transduction systems. Clin Pharmacol Ther 70:210-216
12. Brown RP, Delp MD, Lindstedt SL, Rhomberg LR, Beliles RP (1997) Physiological parameter values for physiologically based pharmacokinetic models. Toxicol Ind Health 13:407-484
13. Leighton JK, Saber H, Lee H (2009) Pharmacology review-Everolimus. Center for Drug Evaluation and Research, Rockville
14. O'Reilly T, McSheehy PM, Kawai R, Kretz O, McMahon L, Brueggen J, Bruelisauer A, Gschwind HP, Allegrini PR, Lane HA (2010) Comparative pharmacokinetics of RAD001 (everolimus) in normal and tumor-bearing rodents. Cancer Chemother Pharmacol 65:625-639
15. Kovarik JM, Kalbag J, Figueiredo J, Rouilly M, Frazier OL, Rordorf C (2002) Differential influence of two cyclosporine formulations on everolimus pharmacokinetics: a clinically relevant pharmacokinetic interaction. J Clin Pharmacol 42:95-99
16. Saber-Mahloogi H, Morse DE (2005) Pharmacology review-Sorafenib. Center for Drug Evaluation and Research, Rockville
17. Jain L, Woo S, Gardner ER, Dahut WL, Kohn EC, Kummar S, Mould DR, Giaccone G, Yarchoan R, Venitz J, Figg WD (2011) Population pharmacokinetic analysis of sorafenib in patients with solid tumours. Br J Clin Pharmacol 72:294-305
18. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Allison MJ, Schmouder RL (2005) Pharmacokinetic interaction between verapamil and everolimus in healthy subjects. Br J Clin Pharmacol 60:434-437
19. Hylander BL, Pitoniak R, Penetrante RB, Gibbs JF, Oktay D, Cheng J, Repasky EA (2005) The anti-tumor effect of Apo2L/TRAIL on patient pancreatic adenocarcinomas grown as xenografts in SCID mice. J Transl Med 3:22
20. Hsieh Y, Galviz G, Long BJ (2009) Ultra-performance hydrophilic interaction liquid chromatography/tandem mass spectrometry for the determination of everolimus in mouse plasma. Rapid Commun Mass Spectrom 23:1461-1466
21. Jain L, Gardner ER, Venitz J, Dahut W, Figg WD (2008) Development of a rapid and sensitive LC-MS/MS assay for the determination of sorafenib in human plasma. J Pharm Biomed Anal 46:362-367
22. Baxter LT, Zhu H, Mackensen DG, Jain RK (1994) Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res 54:1517-1528
23. Davies B, Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095
24. D'Argenio DZ, Schumitzky A, Wang X (2009) ADAPT 5 User's Guide: pharmacokinetic/pharmacodynamic systems analysis software. Biomed Simul Res
25. Pawaskar DK, Straubinger RM, Fetterly GJ, Hylander BH, Repasky EA, Ma WW, Jusko WJ (2012) Synergistic interactions between sorafenib and everolimus in pancreatic cancer xenografts in mice. Cancer Chemother Pharmacol. doi: 10.1007/s00280-013-2117-x
26. Urva SR, Yang VC, Balthasar JP (2010) Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody. J Pharm Sci 99:1582-1600
27. Friedman JJ (1968) Muscle blood flow and 86Rb extraction: 86Rb as a capillary flow indicator. Am J Physiol 214:488-493
28. Hotte SJ, Hirte HW (2002) BAY 43-9006: early clinical data in patients with advanced solid malignancies. Curr Pharm Des 8:2249-2253
29. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Shenouda M, Schmouder RL (2005) Blood concentrations of everolimus are markedly increased by ketoconazole. J Clin Pharmacol 45:514-518
30. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Shenouda M, Schmouder RL (2005) Effect of multiple-dose erythromycin on everolimus pharmacokinetics. Eur J Clin Pharmacol 61:35-38
31. Kovarik JM, Hartmann S, Hubert M, Berthier S, Schneider W, Rosenkranz B, Rordorf C (2002) Pharmacokinetic and pharmacodynamic assessments of HMG-CoA reductase inhibitors when coadministered with everolimus. J Clin Pharmacol 42:222-228
32. Lathia C, Lettieri J, Cihon F, Gallentine M, Radtke M, Sundaresan P (2006) Lack of effect of ketoconazole-mediated CYP3A inhibition on sorafenib clinical pharmacokinetics. Cancer Chemother Pharmacol 57:685-692
33. Gnoth MJ, Sandmann S, Engel K, Radtke M (2010) In vitro to in vivo comparison of the substrate characteristics of sorafenib tosylate toward P-glycoprotein. Drug Metab Dispos 38:1341-1346
34. Chu C, Abbara C, Noel-Hudson MS, Thomas-Bourgneuf L, Gonin P, Farinotti R, Bonhomme-Faivre L (2009) Disposition of everolimus in mdr1a-/1b- mice and after a pre-treatment of lapatinib in Swiss mice. Biochem Pharmacol 77:1629-1634
35. Crowe A, Lemaire M (1998) In vitro and in situ absorption of SDZ-RAD using a human intestinal cell line (Caco-2) and a single pass perfusion model in rats: comparison with rapamycin. Pharm Res 15:1666-1672