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Volumn 43, Issue 1, 2015, Pages 54-62

Mechanistic understanding of translational pharmacokinetic-pharmacodynamic relationships in nonclinical tumor models: A case study of orally available novel inhibitors of anaplastic lymphoma kinase

Author keywords

[No Author keywords available]

Indexed keywords

7 AMINO 12 FLUORO 2,10,16 TRIMETHYL 15 OXO 10,15,16,17 TETRAHYDRO 2H 8,4 (AZENO)PYRAZOLO[4,3 H][2,5,11]BENZOXADIAZACYCLOTETRADECINE 3 CARBONITRILE; 7 AMINO 12 FLUORO 2,10,16 TRIMETHYL 15 OXO 10,15,16,17 TETRAHYDRO 2H 8,4 (METHENO)PYRAZOLO[4,3 H][2,5,11]BENZOXADIAZACYCLOTETRADECINE 3 CARBONITRILE; ANAPLASTIC LYMPHOMA KINASE; ANAPLASTIC LYMPHOMA KINASE INHIBITOR; CRIZOTINIB; ECHINODERM MICROTUBULE ASSOCIATED PROTEIN LIKE 4 ANAPLASTIC LYMPHOMA KINASE FUSION PROTEIN; HYBRID PROTEIN; PHOSPHOTRANSFERASE INHIBITOR; UNCLASSIFIED DRUG; 7-AMINO-12-FLUORO-2,10,16-TRIMETHYL-15-OXO-10,15,16,17-TETRAHYDRO-2H-8,4-(METHENO)PYRAZOLO(4,3-H)(2,5,11)BENZOXADIAZACYCLOTETRADECINE-3-CARBONITRILE; ANTINEOPLASTIC AGENT; MACROCYCLIC LACTAM; MICROTUBULE ASSOCIATED PROTEIN; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE;

EID: 84919683812     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.114.061143     Document Type: Article
Times cited : (22)

References (27)
  • 1
    • 84890282111 scopus 로고    scopus 로고
    • The genetic complexity of common cancers and the promise of personalized medicine: Is there any hope?
    • Arnedos M, Vielh P, Soria JC, and Andre F (2014) The genetic complexity of common cancers and the promise of personalized medicine: is there any hope? J Pathol 232:274-282.
    • (2014) J Pathol , vol.232 , pp. 274-282
    • Arnedos, M.1    Vielh, P.2    Soria, J.C.3    Andre, F.4
  • 4
    • 33644808298 scopus 로고    scopus 로고
    • Pharmacokinetics/ Pharmacodynamics and the stages of drug development: Role of modeling and simulation
    • Chien JY, Friedrich S, Heathman MA, de Alwis DP, and Sinha V (2005) Pharmacokinetics/ Pharmacodynamics and the stages of drug development: role of modeling and simulation. AAPS J 7:E544-E559.
    • (2005) AAPS J , vol.7 , pp. E544-E559
    • Chien, J.Y.1    Friedrich, S.2    Heathman, M.A.3    De Alwis, D.P.4    Sinha, V.5
  • 6
    • 43649102392 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: Designing informative human pharmacology studies
    • Cohen A (2008) Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies. Clin Pharmacokinet 47:373-381.
    • (2008) Clin Pharmacokinet , vol.47 , pp. 373-381
    • Cohen, A.1
  • 8
    • 84919645797 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic data analysis: Concepts and applications
    • 3rd ed. Swedish Pharmaceutical Press, Stockholm, Sweden. Goulart BH, Clark JW, Pien HH, Roberts TG, Finkelstein SN, and Chabner BA (2007)Trends in the use and role of biomarkers in phase I oncology trials
    • Gabrielsson J and Weiner D (2000) Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, 3rd ed. Swedish Pharmaceutical Press, Stockholm, Sweden. Goulart BH, Clark JW, Pien HH, Roberts TG, Finkelstein SN, and Chabner BA (2007)Trends in the use and role of biomarkers in phase I oncology trials. Clin Cancer Res 13:6719-6726.
    • (2000) Clin Cancer Res , vol.13 , pp. 6719-6726
    • Gabrielsson, J.1    Weiner, D.2
  • 10
    • 84902455683 scopus 로고    scopus 로고
    • Discovery of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) with preclinical brain exposure and broad-spectrum potency against ALK-resistant mutations
    • Johnson TW, Richardson PF, Bailey S, Brooun A, Burke BJ, Collins MR, Cui JJ, Deal JG, Deng YL, Dinh D, et al. (2014) Discovery of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) with preclinical brain exposure and broad-spectrum potency against ALK-resistant mutations. J Med Chem 57:4720-4744.
    • (2014) J Med Chem , vol.57 , pp. 4720-4744
    • Johnson, T.W.1    Richardson, P.F.2    Bailey, S.3    Brooun, A.4    Burke, B.J.5    Collins, M.R.6    Cui, J.J.7    Deal, J.G.8    Deng, Y.L.9    Dinh, D.10
  • 11
    • 0027943266 scopus 로고
    • Physiologic indirect response models characterize diverse types of pharmacodynamic effects
    • Jusko WJ and Ko HC (1994) Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 56:406-419.
    • (1994) Clin Pharmacol Ther , vol.56 , pp. 406-419
    • Jusko, W.J.1    Ko, H.C.2
  • 12
    • 0034491130 scopus 로고    scopus 로고
    • Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans
    • Lesko LJ, Rowland M, Peck CC, and Blaschke TF (2000) Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans. Pharm Res 17:1335-1344.
    • (2000) Pharm Res , vol.17 , pp. 1335-1344
    • Lesko, L.J.1    Rowland, M.2    Peck, C.C.3    Blaschke, T.F.4
  • 13
    • 66849118694 scopus 로고    scopus 로고
    • Dose escalation methods in phase I cancer clinical trials
    • Le Tourneau C, Lee JJ, and Siu LL (2009) Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst 101:708-720.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 708-720
    • Le Tourneau, C.1    Lee, J.J.2    Siu, L.L.3
  • 14
    • 84880504574 scopus 로고    scopus 로고
    • Building a personalized medicine infrastructure at a major cancer center
    • Meric-Bernstam F, Farhangfar C, Mendelsohn J, and Mills GB (2013) Building a personalized medicine infrastructure at a major cancer center. J Clin Oncol 31:1849-1857.
    • (2013) J Clin Oncol , vol.31 , pp. 1849-1857
    • Meric-Bernstam, F.1    Farhangfar, C.2    Mendelsohn, J.3    Mills, G.B.4
  • 15
    • 59449085305 scopus 로고    scopus 로고
    • Phase I study of the poly(ADP-ribose) polymerase inhibitor, AG014699, in combination with temozolomide in patients with advanced solid tumors
    • Plummer R, Jones C, Middleton M, Wilson R, Evans J, Olsen A, Curtin N, Boddy A, McHugh P, Newell D, et al. (2008) Phase I study of the poly(ADP-ribose) polymerase inhibitor, AG014699, in combination with temozolomide in patients with advanced solid tumors. Clin Cancer Res 14:7917-7923.
    • (2008) Clin Cancer Res , vol.14 , pp. 7917-7923
    • Plummer, R.1    Jones, C.2    Middleton, M.3    Wilson, R.4    Evans, J.5    Olsen, A.6    Curtin, N.7    Boddy, A.8    McHugh, P.9    Newell, D.10
  • 16
    • 34548853993 scopus 로고    scopus 로고
    • Prospective assessment of discontinuation and reinitiation of erlotinib or gefitinib in patients with acquired resistance to erlotinib or gefitinib followed by the addition of everolimus
    • Riely GJ, Kris MG, Zhao B, Akhurst T, Milton DT, Moore E, Tyson L, Pao W, Rizvi NA, Schwartz LH, et al. (2007) Prospective assessment of discontinuation and reinitiation of erlotinib or gefitinib in patients with acquired resistance to erlotinib or gefitinib followed by the addition of everolimus. Clin Cancer Res 13:5150-5155.
    • (2007) Clin Cancer Res , vol.13 , pp. 5150-5155
    • Riely, G.J.1    Kris, M.G.2    Zhao, B.3    Akhurst, T.4    Milton, D.T.5    Moore, E.6    Tyson, L.7    Pao, W.8    Rizvi, N.A.9    Schwartz, L.H.10
  • 18
    • 0031742890 scopus 로고    scopus 로고
    • Precursor-dependent indirect pharmacodynamic response model for tolerance and rebound phenomena
    • Sharma A, Ebling WF, and Jusko WJ (1998) Precursor-dependent indirect pharmacodynamic response model for tolerance and rebound phenomena. J Pharm Sci 87:1577-1584.
    • (1998) J Pharm Sci , vol.87 , pp. 1577-1584
    • Sharma, A.1    Ebling, W.F.2    Jusko, W.J.3
  • 19
    • 0018394195 scopus 로고
    • Simultaneous modeling of pharmacokinetics and pharmacodynamics: Application to d-tubocurarine
    • Sheiner LB, Stanski DR, Vozeh S, Miller RD, and Ham J (1979) Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther 25:358-371.
    • (1979) Clin Pharmacol Ther , vol.25 , pp. 358-371
    • Sheiner, L.B.1    Stanski, D.R.2    Vozeh, S.3    Miller, R.D.4    Ham, J.5
  • 20
    • 84861203302 scopus 로고    scopus 로고
    • EGFR-mutated oncogene-addicted nonsmall cell lung cancer: Current trends and future prospects
    • Soria JC, Mok TS, Cappuzzo F, and Jänne PA (2012) EGFR-mutated oncogene-addicted nonsmall cell lung cancer: current trends and future prospects. Cancer Treat Rev 38:416-430.
    • (2012) Cancer Treat Rev , vol.38 , pp. 416-430
    • Soria, J.C.1    Mok, T.S.2    Cappuzzo, F.3    Jänne, P.A.4
  • 22
    • 0034954242 scopus 로고    scopus 로고
    • Assessment of actual significance levels for covariate effects in NONMEM
    • Wählby U, Jonsson EN, and Karlsson MO (2001) Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn 28:231-252.
    • (2001) J Pharmacokinet Pharmacodyn , vol.28 , pp. 231-252
    • Wählby, U.1    Jonsson, E.N.2    Karlsson, M.O.3
  • 23
    • 84877018103 scopus 로고    scopus 로고
    • Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: A case study of anticancer drug, crizotinib
    • Yamazaki S (2013) Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: a case study of anticancer drug, crizotinib. AAPS J 15:354-366.
    • (2013) AAPS J , vol.15 , pp. 354-366
    • Yamazaki, S.1
  • 24
    • 84907173819 scopus 로고    scopus 로고
    • Pharmacokineticpharmacodynamic modeling for an orally available novel inhibitor of anaplastic lymphoma kinase inhibition and C-Ros oncogene 1
    • Yamazaki S, Lam L, Helen Y, Zou HY, Smeal T, and Vicini P (2014) Pharmacokineticpharmacodynamic modeling for an orally available novel inhibitor of anaplastic lymphoma kinase inhibition and c-Ros oncogene 1. J Pharmacol Exp Ther 351:67-76.
    • (2014) J Pharmacol Exp Ther , vol.351 , pp. 67-76
    • Yamazaki, S.1    Lam, L.2    Helen, Y.3    Zou, H.Y.4    Smeal, T.5    Vicini, P.6
  • 25
    • 46449090520 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modeling of biomarker response and tumor growth inhibition to an orally available cMet kinase inhibitor in human tumor xenograft mouse models
    • Yamazaki S, Skaptason J, Romero D, Lee JH, Zou HY, Christensen JG, Koup JR, Smith BJ, and Koudriakova T (2008) Pharmacokinetic-pharmacodynamic modeling of biomarker response and tumor growth inhibition to an orally available cMet kinase inhibitor in human tumor xenograft mouse models. Drug Metab Dispos 36:1267-1274.
    • (2008) Drug Metab Dispos , vol.36 , pp. 1267-1274
    • Yamazaki, S.1    Skaptason, J.2    Romero, D.3    Lee, J.H.4    Zou, H.Y.5    Christensen, J.G.6    Koup, J.R.7    Smith, B.J.8    Koudriakova, T.9
  • 26
    • 84863116231 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models
    • Yamazaki S, Vicini P, Shen Z, Zou HY, Lee J, Li Q, Christensen JG, Smith BJ, and Shetty B (2012) Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models. J Pharmacol Exp Ther 340:549-557.
    • (2012) J Pharmacol Exp Ther , vol.340 , pp. 549-557
    • Yamazaki, S.1    Vicini, P.2    Shen, Z.3    Zou, H.Y.4    Lee, J.5    Li, Q.6    Christensen, J.G.7    Smith, B.J.8    Shetty, B.9
  • 27
    • 84919685423 scopus 로고    scopus 로고
    • PF-06463922, a novel ROS1/ALK inhibitor, demonstrates sub-nanomolar potency against oncogenic ROS1 fusions and capable of blocking the resistant ROS1G2032R mutant in preclinical tumor models
    • American Associations for Cancer Research, Washington, DC.
    • Zou HY, Engstrom L, Li Q, Lu MW, Tang RW, Wang H, Timofeevski S, Lam J, Yamazaki S, Hu W, et al. (2013) PF-06463922, a novel ROS1/ALK inhibitor, demonstrates sub-nanomolar potency against oncogenic ROS1 fusions and capable of blocking the resistant ROS1G2032R mutant in preclinical tumor models. Proceedings of the AACR Annual Meeting; 2013 Apr 6-10; American Associations for Cancer Research, Washington, DC.
    • (2013) Proceedings of The AACR Annual Meeting , vol.2013 , Issue.APR , pp. 6-10
    • Zou, H.Y.1    Engstrom, L.2    Li, Q.3    Lu, M.W.4    Tang, R.W.5    Wang, H.6    Timofeevski, S.7    Lam, J.8    Yamazaki, S.9    Hu, W.10


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