Phase 1 study of the investigational Aurora A kinase inhibitor alisertib (MLN8237) in East Asian cancer patients: pharmacokinetics and recommended phase 2 dose

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• 作者：Karthik Venkatakrishnan ; Tae Min Kim ; Chia-Chi Lin…
• 关键词：Pharmacokinetics ; Phase 1 clinical trial ; Alisertib ; Cancer ; Asian
• 刊名：Investigational New Drugs
• 出版年：2015
• 出版时间：August 2015
• 年：2015
• 卷：33
• 期：4
• 页码：942-953
• 全文大小：467 KB
• 参考文献：1.Carvajal RD, Tse A, Schwartz GK (2006) Aurora kinases: new targets for cancer therapy. Clin Cancer Res 12(23):6869鈥?875PubMed View Article
  2.Lu LY, Wood JL, Ye L, Minter-Dykhouse K, Saunders TL, Yu X et al (2008) Aurora A is essential for early embryonic development and tumor suppression. J Biol Chem 283(46):31785鈥?1790PubMed Central PubMed View Article
  3.Barr AR, Gergely F (2007) Aurora-A: the maker and breaker of spindle poles. J Cell Sci 120(Pt 17):2987鈥?996PubMed View Article
  4.Fu J, Bian M, Jiang Q, Zhang C (2007) Roles of Aurora kinases in mitosis and tumorigenesis. Mol Cancer Res 5(1):1鈥?0PubMed View Article
  5.Marumoto T, Honda S, Hara T, Nitta M, Hirota T, Kohmura E et al (2003) Aurora-A kinase maintains the fidelity of early and late mitotic events in HeLa cells. J Biol Chem 278(51):51786鈥?1795PubMed View Article
  6.Gorgun G, Calabrese E, Hideshima T, Ecsedy J, Perrone G, Mani M et al (2010) A novel Aurora-A kinase inhibitor MLN8237 induces cytotoxicity and cell-cycle arrest in multiple myeloma. Blood 115(25):5202鈥?213PubMed Central PubMed View Article
  7.Huck JJ, Zhang M, McDonald A, Bowman D, Hoar KM, Stringer B et al (2010) MLN8054, an inhibitor of Aurora A kinase, induces senescence in human tumor cells both in vitro and in vivo. Mol Cancer Res 8(3):373鈥?84PubMed View Article
  8.Dar AA, Zaika A, Piazuelo MB, Correa P, Koyama T, Belkhiri A et al (2008) Frequent overexpression of Aurora Kinase A in upper gastrointestinal adenocarcinomas correlates with potent antiapoptotic functions. Cancer 112(8):1688鈥?698PubMed Central PubMed View Article
  9.Dutta-Simmons J, Zhang Y, Gorgun G, Gatt M, Mani M, Hideshima T et al (2009) Aurora kinase A is a target of Wnt/beta-catenin involved in multiple myeloma disease progression. Blood 114(13):2699鈥?708PubMed View Article
  10.Evans R, Naber C, Steffler T, Checkland T, Keats J, Maxwell C et al (2008) Aurora A kinase RNAi and small molecule inhibition of Aurora kinases with VE-465 induce apoptotic death in multiple myeloma cells. Leuk Lymphoma 49(3):559鈥?69PubMed View Article
  11.Hoque A, Carter J, Xia W, Hung MC, Sahin AA, Sen S et al (2003) Loss of aurora A/STK15/BTAK overexpression correlates with transition of in situ to invasive ductal carcinoma of the breast. Cancer Epidemiol Biomarkers Prev 12(12):1518鈥?522PubMed
  12.Mazumdar A, Henderson YC, El-Naggar AK, Sen S, Clayman GL (2009) Aurora kinase A inhibition and paclitaxel as targeted combination therapy for head and neck squamous cell carcinoma. Head Neck 31(5):625鈥?34PubMed Central PubMed View Article
  13.Tomita M, Toyota M, Ishikawa C, Nakazato T, Okudaira T, Matsuda T et al (2009) Overexpression of Aurora A by loss of CHFR gene expression increases the growth and survival of HTLV-1-infected T cells through enhanced NF-kappaB activity. Int J Cancer 124(11):2607鈥?615PubMed View Article
  14.Yang SB, Zhou XB, Zhu HX, Quan LP, Bai JF, He J et al (2007) Amplification and overexpression of Aurora-A in esophageal squamous cell carcinoma. Oncol Rep 17(5):1083鈥?088PubMed
  15.Ye D, Garcia-Manero G, Kantarjian HM, Xiao L, Vadhan-Raj S, Fernandez MH et al (2009) Analysis of Aurora kinase A expression in CD34(+) blast cells isolated from patients with myelodysplastic syndromes and acute myeloid leukemia. J Hematop 2(1):2鈥?PubMed Central PubMed View Article
  16.Zhang XH, Rao M, Loprieato JA, Hong JA, Zhao M, Chen GZ et al (2008) Aurora A, Aurora B and survivin are novel targets of transcriptional regulation by histone deacetylase inhibitors in non-small cell lung cancer. Cancer Biol Ther 7(9):1388鈥?397PubMed View Article
  17.Bischoff JR, Anderson L, Zhu Y, Mossie K, Ng L, Souza B et al (1998) A homologue of Drosophila aurora kinase is oncogenic and amplified in human colorectal cancers. EMBO J 17(11):3052鈥?065PubMed Central PubMed View Article
  18.Marumoto T, Zhang D, Saya H (2005) Aurora-A - a guardian of poles. Nat Rev Cancer 5(1):42鈥?0PubMed View Article
  19.Wang X, Zhou YX, Qiao W, Tominaga Y, Ouchi M, Ouchi T et al (2006) Overexpression of aurora kinase A in mouse mammary epithelium induces genetic instability preceding mammary tumor formation. Oncogene 25(54):7148鈥?158PubMed View Article
  20.Manfredi MG, Ecsedy JA, Chakravarty A, Silverman L, Zhang M, Hoar KM et al (2011) Characterization of Alisertib (MLN8237), an investigational small-molecule inhibitor of aurora A kinase using novel in vivo pharmacodynamic assays. Clin Cancer Res 17(24):7614鈥?624PubMed View Article
  21.Carol H, Boehm I, Reynolds CP, Kang MH, Maris JM, Morton CL et al (2011) Efficacy and pharmacokinetic/pharmacodynamic evaluation of the Aurora kinase A inhibitor MLN8237 against preclinical models of pediatric cancer. Cancer Chemother Pharmacol 68(5):1291鈥?304PubMed Central PubMed View Article
  22.Kelly KR, Ecsedy J, Medina E, Mahalingam D, Padmanabhan S, Nawrocki ST et al (2011) The novel Aurora A kinase inhibitor MLN8237 is active in resistant chronic myeloid leukaemia and significantly increases the efficacy of nilotinib. J Cell Mol Med 15(10):2057鈥?070PubMed Central PubMed View Article
  23.Kelly KR, Nawrocki ST, Espitia CM, Zhang M, Yang JJ, Padmanabhan S et al (2012) Targeting Aurora A kinase activity with the investigational agent alisertib increases the efficacy of cytarabine through a FOXO-dependent mechanism. Int J Cancer 131(11):2693鈥?703PubMed Central PubMed View Article
  24.Maris JM, Morton CL, Gorlick R, Kolb EA, Lock R, Carol H et al (2010) Initial testing of the aurora kinase A inhibitor MLN8237 by the pediatric preclinical testing program (PPTP). Pediatr Blood Cancer 55(1):26鈥?4PubMed Central PubMed
  25.Qi W, Spier C, Liu X, Agarwal A, Cooke LS, Persky DO et al (2013) Alisertib (MLN8237) an investigational agent suppresses Aurora A and B activity, inhibits proliferation, promotes endo-reduplication and induces apoptosis in T-NHL cell lines supporting its importance in PTCL treatment. Leuk Res 37(4):434鈥?39PubMed View Article
  26.Sehdev V, Katsha A, Ecsedy J, Zaika A, Belkhiri A, El-Rifai W (2013) The combination of alisertib, an investigational Aurora kinase A inhibitor, and docetaxel promotes cell death and reduces tumor growth in preclinical cell models of upper gastrointestinal adenocarcinomas. Cancer 119(4):904鈥?14PubMed Central PubMed View Article
  27.Tomita M, Mori N (2010) Aurora A selective inhibitor MLN8237 suppresses the growth and survival of HTLV-1-infected T-cells in vitro. Cancer Sci 101(5):1204鈥?211PubMed View Article
  28.Cervantes A, Elez E, Roda D, Ecsedy J, Macarulla T, Venkatakrishnan K et al (2012) Phase I pharmacokinetic/pharmacodynamic study of MLN8237, an investigational, oral, selective aurora a kinase inhibitor, in patients with advanced solid tumors. Clin Cancer Res 18(17):4764鈥?774PubMed View Article
  29.Dees EC, Cohen RB, von Mehren M, Stinchcombe TE, Liu H, Venkatakrishnan K et al (2012) Phase I study of aurora A kinase inhibitor MLN8237 in advanced solid tumors: safety, pharmacokinetics, pharmacodynamics, and bioavailability of two oral formulations. Clin Cancer Res 18(17):4775鈥?784PubMed View Article
  30.Falchook G, Kurzrock R, Gouw L, Hong D, McGregor KA, Zhou X et al (2014) Investigational Aurora A kinase inhibitor alisertib (MLN8237) as an enteric-coated tablet formulation in non-hematologic malignancies: phase 1 dose-escalation study. Investig New Drugs 32(6):1181鈥?187View Article
  31.Kelly KR, Shea TC, Goy A, Berdeja JG, Reeder CB, McDonagh KT et al (2014) Phase I study of MLN8237-investigational Aurora A kinase inhibitor-in relapsed/refractory multiple myeloma, Non-Hodgkin lymphoma and chronic lymphocytic leukemia. Investig New Drugs 32(3):489鈥?99View Article
  32.Beltran H, Rubin MA, Mosquera JM, Christos PJ, Calukovic O, Karpenko I et al (2013) A phase II trial of the aurora kinase A inhibitor MLN8237 in patients with metastatic castrate resistant and neuroendocrine prostate cancer. (Abstract). J Clin Oncol (ASCO 2013 Annual Meeting) 31(Suppl): Abstract TPS5096.
  33.Dickson MA, Mahoney MR, Tap WD, D鈥橝ngelo SP, Keohan ML, Van Tine BA et al (2014) Alliance A091102: Phase II study of MLN8237 (alisertib) in advanced/metastatic sarcoma (Abstract). J Clin Oncol (ASCO 2014 Annual Meeting) 32(5s):Abstract 10527.
  34.Friedberg JW, Mahadevan D, Cebula E, Persky D, Lossos I, Agarwal AB et al (2014) Phase II study of alisertib, a selective Aurora A kinase inhibitor, in relapsed and refractory aggressive B- and T-cell non-Hodgkin lymphomas. J Clin Oncol 32(1):44鈥?0PubMed Central PubMed View Article
  35.Matulonis UA, Sharma S, Ghamande S, Gordon MS, Del Prete SA, Ray-Coquard I et al (2012) Phase II study of MLN8237 (alisertib), an investigational Aurora A kinase inhibitor, in patients with platinum-resistant or -refractory epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Gynecol Oncol 127(1):63鈥?9PubMed View Article
  36.Melichar B, Adenis A, Lockhart AC, Bennouna J, Dees EC, Kayaleh O et al (2015) Safety and activity of alisertib, an investigational aurora kinase A inhibitor, in patients with breast cancer, small-cell lung cancer, non-small-cell lung cancer, head and neck squamous-cell carcinoma, and gastro-oesophageal adenocarcinoma: a five-arm phase 2 study. Lancet Oncol 16(4):395鈥?05PubMed View Article
  37.Venkatakrishnan K, Zhou X, Ecsedy J, Mould DR, Liu H, Danaee H et al (2014) Dose selection for the investigational anticancer agent alisertib (MLN8237): pharmacokinetics, pharmacodynamics, and exposure-safety relationships. J Clin Pharmacol. doi:10.鈥?002/鈥媕cph.鈥?10
  38.ICH Expert Working Group (2005) ICH harmonised tripartite guideline. Ethnic factors in the acceptability of foreign clinical data E5(R1). http://鈥媤ww.鈥媔ch.鈥媜rg/鈥媐ileadmin/鈥婸ublic_鈥媁eb_鈥婼ite/鈥婭CH_鈥婸roducts/鈥婫uidelines/鈥婨fficacy/鈥婨5_鈥婻1/鈥婼tep4/鈥婨5_鈥婻1_鈥媉鈥婫uideline.鈥媝df
  39.Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L et al (2006) 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 24(19):3187鈥?205PubMed View Article
  40.Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228鈥?47PubMed View Article
  41.Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ et al (2007) Revised response criteria for malignant lymphoma. J Clin Oncol 25(5):579鈥?86PubMed View Article
  42.Asano K, Tanaka A, Sato T, Uyama Y (2013) Regulatory challenges in the review of data from global clinical trials: the PMDA perspective. Clin Pharmacol Ther 94(2):195鈥?98PubMed View Article
  43.Zhou X, Pusalkar S, Chowdhury S, Searle S, Li Y, Mertz J et al (2013) Mass balance, routes of excretion and pharmacokinetics of investigational oral [14C] alisertib (MLN8237) in patients with advanced solid tumors or lymphoma (Abstract). AACR-NCI-EORTC 2013 Symposium on Molecular Targets and Cancer Therapeutics Annual Meeting: Abstract B216.
  44.Barter ZE, Tucker GT, Rowland-Yeo K (2013) Differences in cytochrome p450-mediated pharmacokinetics between chinese and caucasian populations predicted by mechanistic physiologically based pharmacokinetic modelling. Clin Pharmacokinet 52(12):1085鈥?100PubMed View Article
  45.Bray F, Jemal A, Grey N, Ferlay J, Forman D (2012) Global cancer transitions according to the human development index (2008鈥?030): a population-based study. Lancet Oncol 13(8):790鈥?01PubMed View Article
  46.Ichimaru K, Toyoshima S, Uyama Y (2010) Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin Pharmacol Ther 87(3):362鈥?66PubMed View Article
  
• 作者单位：Karthik Venkatakrishnan (1)
  Tae Min Kim (2)
  Chia-Chi Lin (3)
  Lim Soon Thye (4)
  Wee Joo Chng (5)
  Brigette Ma (6)
  Ming Huang Chen (7)
  Xiaofei Zhou (1)
  Hua Liu (8)
  Virginia Kelly (9)
  Won Seog Kim (10)
  
  1. Clinical Pharmacology, Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA
  2. Seoul National University Hospital, Seoul, Republic of Korea
  3. National Taiwan University Hospital, Taipei, Taiwan
  4. National Cancer Centre Singapore, Duke-National University of Singapore Graduate School of Medicine, Singapore, Singapore
  5. Cancer Science Institute of Singapore, National University of Singapore, Singapore, Singapore
  6. Department of Clinical Oncology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong
  7. Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan
  8. Statistics, Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA
  9. Oncology Clinical Research, Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA
  10. Samsung Medical Center, Gangnam-Gu, Republic of Korea
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Pharmacology and Toxicology
  
• 出版者：Springer Netherlands
• ISSN：1573-0646

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