A phase 1 study of the sachet formulation of the oral dual PI3K/mTOR inhibitor BEZ235 given twice daily (BID) in patients with advanced solid tumors

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• 作者：Johanna C. Bendell (1) (2) (4)
  Carla Kurkjian (1) (3)
  Jeffrey R. Infante (1) (2)
  Todd M. Bauer (1) (2)
  Howard A. Burris III (1) (2)
  F. Anthony Greco (1) (2)
  Kent C. Shih (1) (2)
  Dana S. Thompson (1) (2)
  Cassie M. Lane (1)
  Lindsey H. Finney (1)
  Suzanne F. Jones (1)
  
  1. Sarah Cannon Research Institute ; Nashville ; TN ; USA
  2. Tennessee Oncology ; PLLC ; Nashville ; TN ; USA
  4. 250 25th Avenue North ; Suite 200 ; Nashville ; TN ; 37203 ; USA
  3. Stephenson Cancer Center ; Oklahoma City ; UK
  
• 关键词：BEZ235 ; PI3K/mTOR ; Sachet formulation ; Dose escalation
• 刊名：Investigational New Drugs
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：33
• 期：2
• 页码：463-471
• 全文大小：1,097 KB
• 参考文献：1. Bachman, KE, Argani, P, Samuels, Y, Silliman, N, Ptak, J, Szabo, S, Konishi, H, Karakas, B, Blair, BG, Lin, C, Peters, BA, Velculescu, VE, Park, BH (2004) The PIK3CA gene is mutated with high frequency in human breast cancers. Cancer Biol Ther 3: pp. 772-775 8.994" target="_blank" title="It opens in new window">CrossRef
  2. Samuels, Y, Diaz, LA, Schmidt-Kittler, O, Cummins, JM, Delong, L, Cheong, I, Rago, C, Huso, DL, Lengauer, C, Kinzler, KW, Vogelstein, B, Velculescu, VE (2005) Mutant PIK3CA promotes cell growth and invasion of human cancer cells. Cancer Cell 7: pp. 561-573 CrossRef
  3. Samuels, Y, Wang, Z, Bardelli, A, Silliman, N, Ptak, J, Szabo, S, Yan, H, Gazdar, A, Powell, SM, Riggins, GJ, Willson, JK, Markowitz, S, Kinzler, KW, Vogelstein, B, Velculescu, VE (2004) High frequency of mutations of the PIK3CA gene in human cancers. Science 304: pp. 554 CrossRef
  4. Kang, S, Bader, AG, Vogt, PK (2005) Phosphatidylinositol 3-kinase mutations identified in human cancer are oncogenic. Proc Natl Acad Sci U S A 102: pp. 802-807 8864102" target="_blank" title="It opens in new window">CrossRef
  5. Cantley, LC, Neel, BG (1999) New insights into tumor suppression: PTEN suppresses tumor formation by restraining the phosphoinositide 3-kinase/AKT pathway. Proc Natl Acad Sci U S A 96: pp. 4240-4245 8.4240" target="_blank" title="It opens in new window">CrossRef
  6. Cully, M, You, H, Levine, AJ, Mak, TW (2006) Beyond PTEN mutations: the PI3K pathway as an integrator of multiple inputs during tumorigenesis. Nat Rev Cancer 6: pp. 184-192 8/nrc1819" target="_blank" title="It opens in new window">CrossRef
  7. Burris, H, Rodon, J, Sharma, S, Herbst, RS, Tabernero, J, Infante, JR, Silva, A, Demanse, D, Hackl, W, Baselga, J (2010) First-in-human phase I study of the oral PI3K inhibitor BEZ235 in patients (pts) with advanced solid tumors. ASCO Meet Abstr 28: pp. 3005
  8. Peyton, JD, Rodon Ahnert, J, Burris, H, Britten, C, Chen, LC, Tabernero, J, Duval, V, Rouyrre, N, Silva, AP, Quadt, C, Baselga, J (2011) A dose-escalation study with the novel formulation of the oral pan-class I PI3K inhibitor BEZ235, solid dispersion system (SDS) sachet, in patients with advanced solid tumors. ASCO Meet Abstr 29: pp. 3066
  9. NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4. http://evs.nci.nih.gov/ftp1/CTCAE/About.html, National Cancer Institute (acessed October, 2014)
  10. Eisenhauer, E, Therasse, P, Bogaerts, J, Schwartz, LH, Sargent, D, Ford, R, Dancey, J, Arbuck, S, Gwyther, S, Mooney, M, Rubinstein, L, Shankar, L, Dodd, L, Kaplan, R, Lacombe, D, Verweij, J (2009) New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer 45: pp. 228-247 8.10.026" target="_blank" title="It opens in new window">CrossRef
  11. Brana, I, LoRusso, P, Baselga, J, Heath, EI, Patnaik, A, Gendreau, S, Laird, A, Papadopoulos, K (2010) A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies. ASCO Meet Abstr 28: pp. 3030
  12. Hollebecque A, Clamp A, Horsley L, Morgan JA, Bahleda R, George S, Shaw D, Lauchle JO, Ware J, Desai R, Wu J, Fu L, Jayson GC, Soria JC, Wagner AJ 12. Hollebecque A, Clamp A, Horsley L (2011) A phase I study evaluating the pharmokinetics (PK) and pharmodynamics (PD) activity of the dual PI3K/mTOR inhibitor GDC-0980 administered once weekly (QW). AACR/NCI/EORTC Molecular Targets and Cancer Therapeutics Meeting Abstract B153
  13. Millham R, Houk B, Borzillo G (2011) First-in-patient study of PF-04691502, a small molecule intravenous dual inhibitor of PI3K and mTOR in patients with advanced cancer: update on safety, efficacy, and pharmacology. AACR/NCI/EORTC Molecular Targets and Cancer Therapeutics Meeting Abstract B163
  14. Munster PN, van der Noll R, Voest EE, Dees EC, Tan AR, Specht JM, Falchook GS, Daud A, Lolkema MP, Grilley-Olson JE, Yu EY, Fu S, Bergsland EK, Kleha J, Peng S, Smith DA, Lampkin TA, Schellens JHM, Morris SR, R. Kurzrock R (2011) Phase I first-in-human study of the PI3 kinase inhibitor GSK2126458 (GSK458) in patients with advanced solid tumors (study P3K112826). ASCO Meeting Abstracts 29:3018
  15. Shapiro, GI, Rodon, J, Bedell, C, Kwak, EL, Baselga, J, Bra帽a, I, Pandya, SS, Scheffold, C, Laird, AD, Nguyen, LT, Xu, Y, Egile, C, Edelman, G (2014) Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245408 (XL147), an oral pan-class I PI3K inhibitor, in patients with advanced solid tumors. Clin Cancer Res 20: pp. 233-245 8/1078-0432.CCR-13-1777" target="_blank" title="It opens in new window">CrossRef
  16. Burris H, Rodon J, Sharma S, Herbst RS, Tabernero J, Infante JR, Silva A, Demanse D, Hackl W, Baselga J (2010) First-in-human phase I study of the oral dual PI3K and mTORC1/2 inhibitor BEZ235 in patients with advanced solid tumors. ASCO Meeting Oral Presentation 3005
  17. Hollebecque, A, Clamp, A, Horsley, L (2011) A phase 1 study evaluating the pharmacokinetics (PK) and pharmacodynamic (PD) activity of the dual PI3K/mTOR inhibitor GDC-0980 administered once weekly (QW). American Association for Cancer Research, Orlando
  18. Millham R, Houk B, Borzillo G (2011) First-in-patient study of PF-049691502, a small molecule intravenous dual inhibitor of PI3K and mTOR in patients with advanced cancer: update on safety, efficacy, and pharmacology. AACR-NCI-EORTC International Conference on Molecular Target and Cancer Therapeutics San Franciso, CA, Abstract B163
  19. Campone M, Fumoleau P, Gil-Martin M, Isambert N, Beck JT, Becerra C, Shtivelband M, Duval V, di Tomaso E, Roussou P, Urban P, Urruticoechea A (2012) A multicenter, open-label Ph IB/II study of BEZ235, an oral dual PI3K/mTOR inhibitor, in combination with paclitaxel in patients with HER2-negative, locally advanced or metastatic breast cancer. San Antonio Breast Cancer Symposium Abstract:P6-11-08
  20. Mayer IA, Abramson VG, Balko JM, Isakoff SJ, Forero A, Kuba MG, Sanders ME, Li Y, Winer E, Arteaga CL (2012) SU2C phase 1b trial of dual PI3K/ mTOR inhibitor BEZ235 with letrozole in ER+/HER2- METASTATIC BREAST CANCER (MBC). San Antonio Breast Cancer Symposium Abstract: P6-10-05
  21. Ahnert, JR, Schuler, MH, Machiels J-P, H, Hess, D, Paz-Ares, L, Awada, A, Moos, R, Steeghs, N, Zambrano, CC, Peggy De Mesmaeker, P, Richly, H, Herremans, C, Joerger, M, Jaime, JC, Alsina, M, Baffert, F, Demanse, D, Duval, V, Morozov, A, Dirix, L (2014) Phase lb study of BEZ235 plus either paclitaxel (PTX) in advanced solid tumors (aST) or PTX plus trastuzumab (TZ) in HER2+ breast cancer (BC). ASCO Meet Abstr 32: pp. 621
  22. Siegel, AP, Bryce, AH, Lin, AM, Friedlander, TW, Hsieh, AC, Hang, E, Weinberg, VK, Ryan, CJ (2014) Results of a multicenter phase I/II trial of abiraterone acetate plus BEZ235 in metastatic, castration-resistant prostate cancer (mCRPC). ASCO Meet Abstr 32: pp. e16042
  
• 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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