Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults

Cancer Chemotherapy and Pharmacology

Volumn 63, Issue 2, 2009, Pages 229-238

  Menon Andersen, Divya ^a   Mondick, John T ^a   Jayaraman, Bhuvana ^a   Thompson, Patrick A ^b   Blaney, Susan M ^b   Bernstein, Mark ^c   Bond, Mason ^d   Champagne, Martin ^e   Fossler, Michael J ^f   Barrett, Jeffrey S ^a  

^a CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^b TEXAS CHILDREN S CANCER CENTER   (United States)

^c IWK HEALTH CENTRE   (Canada)

^d BC CHILDREN S HOSPITAL   (Canada)

^e UNIVERSITY OF MONTREAL   (Canada)

^f UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Imatinib; Pediatric; Ph+ leukemia; Population pharmacokinetics; Refractory solid tumors

Indexed keywords

2 [2 METHYL 5 [4 (1 PIPERAZINYLMETHYL)BENZAMIDO]ANILINO] 4 (3 PYRIDYL)PYRIMIDINE; ALANINE AMINOTRANSFERASE; ALBUMIN; DRUG METABOLITE; IMATINIB;

ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALBUMIN BLOOD LEVEL; ARTICLE; BODY SURFACE; BODY WEIGHT; CHILD; CHRONIC MYELOID LEUKEMIA; DESMOPLASTIC SMALL ROUND CELL TUMOR; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISPOSITION; DRUG EXPOSURE; EWING SARCOMA; GASTROINTESTINAL STROMAL TUMOR; HUMAN; NEUROBLASTOMA; OSTEOSARCOMA; PHILADELPHIA CHROMOSOME POSITIVE CELL; PRIORITY JOURNAL; SOLID TUMOR; SYNOVIAL SARCOMA;

ADMINISTRATION, ORAL; ADOLESCENT; AGING; ANTINEOPLASTIC AGENTS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GASTROINTESTINAL STROMAL TUMORS; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MALE; MODELS, BIOLOGICAL; MULTIVARIATE ANALYSIS; PIPERAZINES; PYRIMIDINES; YOUNG ADULT;

EID: 57249088703     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-008-0730-x     Document Type: Article

References (31)

1. A Abdiu S Wingren SE Larsson A Wasteson TM Walz 1999 Effects of human platelet-derived growth factor-AB on sarcoma growth in vitro and in vivo Cancer Lett 141 39 45
2. R Bakhtiar J Lohne L Ramos L Khemani M Hayes F Tse 2002 High-throughput quantification of the anti-leukemia drug STI571 (Gleevec) and its main metabolite (CGP 74588) in human plasma using liquid chromatography-tandem mass spectrometry J Chromatogr B Analyt Technol Biomed Life Sci 768 325 340
3. IH Bartelink CM Rademaker AF Schobben JN van den Anker 2006 Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations Clin Pharmacokinet 45 1077 1097
4. Beal SL, Sheiner LB (1992) NONMEM users guides. NONMEM Project Group, University of California at San Francisco
5. Bond M, Bernstein ML, Pappo A, Schultz KR, Krailo M, Blaney SM, Adamson PC (2007) A phase II study of imatinib mesylate in children with refractory or relapsed solid tumors: a children's oncology group study. Pediatr Blood Cancer
6. MA Champagne R Capdeville M Krailo W Qu B Peng M Rosamilia M Therrien U Zoellner SM Blaney M Bernstein 2004 Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a children's oncology group phase 1 study Blood 104 2655 2660
7. MH Cohen G Williams JR Johnson J Duan J Gobburu A Rahman K Benson J Leighton SK Kim R Wood M Rothmann G Chen KM U AM Staten R Pazdur 2002 Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia Clin Cancer Res 8 935 942
8. R Dagher M Cohen G Williams M Rothmann J Gobburu G Robbie A Rahman G Chen A Staten D Griebel R Pazdur 2002 Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors Clin Cancer Res 8 3034 3038
9. SN de Wildt GL Kearns JS Leeder JN van den Anker 1999 Cytochrome P450 3A:ontogeny and drug disposition Clin Pharmacokinet 37 485 505
10. MW Deininger JM Goldman N Lydon JV Melo 1997 The tyrosine kinase inhibitor CGP57148B selectively inhibits the growth of BCR-ABL-positive cells Blood 90 3691 3698
11. C Delbaldo E Chatelut M Re A Deroussent S Seronie-Vivien A Jambu P Berthaud A Le Cesne JY Blay G Vassal 2006 Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors Clin Cancer Res 12 6073 6078
12. BJ Druker S Tamura E Buchdunger S Ohno GM Segal S Fanning J Zimmermann NB Lydon 1996 Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells Nat Med 2 561 566
13. FDA 2003 FDA approves Gleevec for pediatric leukemia FDA Consum 37 4 6
14. HP Gschwind U Pfaar F Waldmeier M Zollinger C Sayer P Zbinden M Hayes R Pokorny M Seiberling M Ben-Am B Peng G Gross 2005 Metabolism and disposition of imatinib mesylate in healthy volunteers Drug Metab Dispos 33 1503 1512
15. MC Heinrich DJ Griffith BJ Druker CL Wait KA Ott AJ Zigler 2000 Inhibition of c-kit receptor tyrosine kinase activity by STI 571, a selective tyrosine kinase inhibitor Blood 96 925 932
16. Holford NH (2005) The visual predictive check-superiority to standard diagnostic plots. In: 2005 population approach group in Europe (PAGE) annual meeting, Pamplona, Spain
17. I Judson P Ma B Peng J Verweij A Racine ED di Paola M van Glabbeke S Dimitrijevic M Scurr H Dumez A van Oosterom 2005 Imatinib pharmacokinetics in patients with gastrointestinal stromal tumour: a retrospective population pharmacokinetic study over time. EORTC soft tissue and bone sarcoma group Cancer Chemother Pharmacol 55 379 386
18. P le Coutre KA Kreuzer S Pursche M Bonin T Leopold G Baskaynak B Dorken G Ehninger O Ottmann A Jenke M Bornhauser E Schleyer 2004 Pharmacokinetics and cellular uptake of imatinib and its main metabolite CGP74588 Cancer Chemother Pharmacol 53 313 323
19. K Neville RA Parise P Thompson A Aleksic MJ Egorin FM Balis L McGuffey C McCully SL Berg SM Blaney 2004 Plasma and cerebrospinal fluid pharmacokinetics of imatinib after administration to nonhuman primates Clin Cancer Res 10 2525 2529
20. Z Nikolova B Peng M Hubert M Sieberling U Keller YY Ho H Schran R Capdeville 2004 Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules Cancer Chemother Pharmacol 53 433 438
21. ® (imatinib mesylate): prescribing information [online]
22. B Peng C Dutreix G Mehring MJ Hayes M Ben-Am M Seiberling R Pokorny R Capdeville P Lloyd 2004 Absolute bioavailability of imatinib (Glivec) orally versus intravenous infusion J Clin Pharmacol 44 158 162
23. B Peng M Hayes D Resta A Racine-Poon BJ Druker M Talpaz CL Sawyers M Rosamilia J Ford P Lloyd R Capdeville 2004 Pharmacokinetics and pharmacodynamics of imatinib in a phase I trial with chronic myeloid leukemia patients J Clin Oncol 22 935 942
24. B Peng P Lloyd H Schran 2005 Clinical pharmacokinetics of imatinib Clin Pharmacokinet 44 879 894
25. S Ramalingam TF Lagattuta MJ Egorin MJ Hayes RK Ramanathan 2004 Biliary excretion of imatinib mesylate and its metabolite CGP 74588 in humans Pharmacotherapy 24 1232 1235
26. DG Savage KH Antman 2002 Imatinib mesylate-a new oral targeted therapy N Engl J Med 346 683 693
27. H Schmidli B Peng GJ Riviere R Capdeville M Hensley I Gathmann AE Bolton A Racine-Poon 2005 Population pharmacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukaemia:results of a phase III study Br J Clin Pharmacol 60 35 44
28. T Sjoblom A Shimizu KP O'Brien K Pietras P Dal Cin E Buchdunger JP Dumanski A Ostman CH Heldin 2001 Growth inhibition of dermatofibrosarcoma protuberans tumors by the platelet-derived growth factor receptor antagonist STI571 through induction of apoptosis Cancer Res 61 5778 5783
29. I Sulzbacher M Traxler I Mosberger S Lang A Chott 2000 Platelet-derived growth factor-AA and -alpha receptor expression suggests an autocrine and/or paracrine loop in osteosarcoma Mod Pathol 13 632 637
30. GR Wilkinson 1996 Cytochrome P4503A (CYP3A) metabolism: prediction of in vivo activity in humans J Pharmacokinet Biopharm 24 475 490
31. Y Yano SL Beal LB Sheiner 2001 Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check J Pharmacokinet Pharmacodyn 28 171 192