Phase 1 clinical trial of the novel proteasome inhibitor marizomib with the histone deacetylase inhibitor vorinostat in patients with melanoma, pancreatic and lung cancer based on in vitro assessments of the combination
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  • 作者:Michael Millward (1)
    Timothy Price (2)
    Amanda Townsend (2)
    Christopher Sweeney (3)
    Andrew Spencer (4)
    Shawgi Sukumaran (2)
    Angie Longenecker (7)
    Lonnie Lee (7)
    Ana Lay (7)
    Girish Sharma (6)
    Robert M. Gemmill (6)
    Harry A. Drabkin (6)
    G. Kenneth Lloyd (7)
    Saskia T. C. Neuteboom (7)
    David J. McConkey (5)
    Michael A. Palladino (7)
    Matthew A. Spear (7)
  • 关键词:Proteasome ; Marizomib ; NPI ; 0052 ; Melanoma ; Lung cancer ; Pancreatic cancer
  • 刊名:Investigational New Drugs
  • 出版年:2012
  • 出版时间:December 2012
  • 年:2012
  • 卷:30
  • 期:6
  • 页码:2303-2317
  • 全文大小:688KB
  • 参考文献:1. Ahn KS, Sethi G, Chao TH, Neuteboom S, Chaturvedi M, Palladino M, Younes A, Aggarwal B (2007) Salinosporamide A (NPI-0052) potentiates apoptosis, suppresses osteoclastogenesis, and inhibits invasion through downmodulation of NF-kB regulated gene products. Blood 110:2286鈥?295 g/10.1182/blood-2007-04-084996">CrossRef
    2. Chauhan D, Catley L, Li G, Podar K, Hideshima T, Velankar M, Mitsiades C, Mitsiades N, Yasui H, Letai A, Ovaa H, Berkers C, Nicholson B, Chao T, Neuteboom S, Richardson P, Palladino M, Anderson K (2005) A novel orally active proteasome inhibitor induces apoptosis in multiple myeloma cells with mechanisms distinct from bortezomib. Cancer Cell 8:407鈥?19 g/10.1016/j.ccr.2005.10.013">CrossRef
    3. Price T, Millward M, Mainwaring P, Harrison S, Catley L, Townsend A, Sukumaran S, Longenecker A, Palladino MA, Lloyd GK, Neuteboom STC, Padrik P, Spear MA, Spencer A (2009) A 2 arm phase 1 clinical trial with NPI-0052 (a novel proteasome inhibitor). EORTC-AACR-NCI Int Conf Molecular Targets and Cancer Therapeutic
    4. Hofmeister CC, Richardson P, Zimmerman T, Spear MA, Palladino MA, Longenecker AM, Cropp GF, Lloyd GK, Hannah AL, Anderson K (2009) Clinical trial of the novel structure proteasome inhibitor NPI-0052 in patients with relapsed and relapsed/refractory multiple myeloma (r/r MM). J Clin Oncol 27:15聽s (8505)
    5. Hamlin PA, Aghajanian C, Younes A, Hong DS, Palladino MA, Longenecker AM, Lloyd GK, Hannah AL, Spear MA, Kurzrock R (2009) First-in-human phase I study of the novel structure proteasome inhibitor NPI-0052. J Clin Oncol 27:15聽s (3516)
    6. Taylor MD, Liu Y, Nagji AS, Theodosakis N, Jones DR (2010) Combined proteasome and histone deacetylase inhibition attenuates epithelial-mesenchymal transition through E-cadherin in esophageal cancer cells. J Thorac Cardiovasc Surg 139(5):1224鈥?232, 1232.e1 g/10.1016/j.jtcvs.2010.01.039">CrossRef
    7. Zolinza (vorinostat) (2006) Prescribing information. Merck, Inc., Whitehouse Station, New Jersey, USA
    8. Miller CP, Rudra S, Keating MJ, Wierda WG, Palladino M, Chandra J (2009) Caspase-8 dependent histone acetylation by a novel proteasome inhibitor, NPI-0052: a mechanism for synergy in leukemia cells. Blood 113:4289鈥?299 g/10.1182/blood-2008-08-174797">CrossRef
    9. Wray C, Fournier KF, Sundi D, Marquis LM, McConkey DJ (2008) Combination proteasome- and histone deacetylase (HDAC) inhibitor treatment of pancreatic cancer. Proc Am Soc Clin Onc Gastroint Canc 259
    10. Cropp GF (2009) NPI-0052-103 clinical pharmacokinetics memo. Report 1035鈥?31. MPI Inc., State College, PA
    11. Chou TC, Talalay P (1984) Quantitative analysis of dose-effect relationships: the combined effects of multiple drugs or enzyme inhibitors. Adv Enzyme Regul 22:27鈥?5 g/10.1016/0065-2571(84)90007-4">CrossRef
    12. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC (1997) Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 6;89(15): 1138鈥?7
    13. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada JNCI 93(3): 205鈥?6
    14. Miller C, Ban K, Dujka M, McConkey D, Palladino M, Chandra J (2007) NPI-0052, a novel proteasome inhibitor, induces caspase-8 and ROS dependent apoptosis alone and in combination with HDAC inhibitors in leukemia cells. Blood 110:267鈥?77 g/10.1182/blood-2006-03-013128">CrossRef
    15. Richardson P, Hofmeister C, Jakubowiak A, Zimmerman TM, Spear MA, Palladino MA, Longenecker AM, Kelly SL, Neuteboom SN, Cropp GF, Lloyd GK, Hannah AL, Anderson KC (2009) Phase 1 Clinical Trial of the Novel Structure Proteasome Inhibitor NPI-0052 in Patients with Relapsed and Relapsed/Refractory Multiple Myeloma (MM). Am. Soc Hem
    16. Badros A, Burger A, Philip S, Niesvizky R, Kolla S, Goloubeva O, Harris C, Zwiebel J, Wright J, Espinoza-Delgado I, Baer M, Holleran J, Egorin M, Grant S (2009) Phase I study of vorinostat in combination with bortezomib for relapsed and refractory multiple myeloma. Clin Cancer Res 15(16):5250鈥?257 g/10.1158/1078-0432.CCR-08-2850">CrossRef
    17. Jagannath S, Siegel DS, Hajek R, Dimopoulos MA, Yoon S, Lonial S, Graef T, Lupinacci L, Reiser D, Anderson KC (2010) Update on vantage program to assess combined vorinostat (V) and bortezomib (B) in patients (pts) with relapsed and/or refractory (RR) multiple myeloma (MM). J Clin Oncol 28:15聽s, (suppl; abstr 8133)
    18. Olsen EA, Kim YH, Kuzel TM et al (2007) Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol 25:3109鈥?115 g/10.1200/JCO.2006.10.2434">CrossRef
    19. Kikuchi J, Wada T, Shimizu R, Izumi T, Akutsu M, Mitsunaga K, Noborio-Hatano T, Nobuyoshi M, Ozawa K, Kano Y, Furukawa Y (2010) Histone deacetylases are critical targets of bortezomib-induced cytotoxicity in multiple myeloma. Blood 22:406鈥?17 g/10.1182/blood-2009-07-235663">CrossRef
    20. McConkey D (2010) Proteasome and HDAC: who鈥檚 zooming who? Blood 22:308鈥?09 g/10.1182/blood-2010-04-278507">CrossRef
    21. Ninan JA, Bailey H, Kolesar J, Marnocha R, Eickhoff J, Wright J, Espinoza-Delgado I, Alberti D, Wilding G, Schelman W (2009) A phase I study of vorinostat in combination with bortezomib in refractory solid tumors. J Clin Oncol 27:15聽s, (suppl; abstr 2531)
    22. Su Y, Amiri KI, Horton LW, Yu Y, Ayers GD, Koehler E, Kelley MC, Puzanov I, Richmond A, Sosman JA (2010) A phase I trial of bortezomib with temozolomide in patients with advanced melanoma: toxicities, antitumor effects, and modulation of therapeutic targets. Clin Cancer Res 16(1):348鈥?57, Epub 2009 Dec 22 g/10.1158/1078-0432.CCR-09-2087">CrossRef
    23. Haas NB, McWhirter E, Hogg D, Martin LP, Polintan R, Litwin S, Wang L, Alpaugh RK, Zwiebel JA, Oza AM (2010) Phase II study of vorinostat in patients with advanced melanoma. J Clin Oncol 28:15聽s, (suppl; abstr 8530)
    24. Geyer SM, Markovic SM, Fitch TR, Albertini MR, Maples WJ, Fracasso PM , Erlichman C (2004) Phase 2 study of PS-341 (bortezomib) in the treatment of metastatic malignant melanoma (MMM). J Clin Oncol. Vol 22, No 14S (July 15 Supplement), 7526
  • 作者单位:Michael Millward (1)
    Timothy Price (2)
    Amanda Townsend (2)
    Christopher Sweeney (3)
    Andrew Spencer (4)
    Shawgi Sukumaran (2)
    Angie Longenecker (7)
    Lonnie Lee (7)
    Ana Lay (7)
    Girish Sharma (6)
    Robert M. Gemmill (6)
    Harry A. Drabkin (6)
    G. Kenneth Lloyd (7)
    Saskia T. C. Neuteboom (7)
    David J. McConkey (5)
    Michael A. Palladino (7)
    Matthew A. Spear (7)

    1. Sir Charles Gairdner Hospital, University of Western Australia, Perth, Australia
    2. The Queen Elizabeth Hospital, Adelaide, Australia
    3. Royal Adelaide Hospital, Adelaide, Australia
    4. The Alfred Hospital, Melbourne, Australia
    7. Nereus Pharmaceuticals, Inc, 10480 Wateridge Circle, San Diego, CA, 92121, USA
    6. Department of Medical University of South Carolina, Charleston, SC, USA
    5. MD Anderson Cancer Center, Houston, TX, USA
  • ISSN:1573-0646
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