메뉴 건너뛰기




Volumn 165, Issue 4, 2016, Pages 270-278

Genomic alteration-driven clinical trial designs in oncology

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DNA POLYMORPHISM; HUMAN; NEOPLASM; ONCOGENE; PERSONALIZED MEDICINE; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STUDY DESIGN; GENOMICS; METHODOLOGY; NEOPLASMS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PROCEDURES;

EID: 84982175048     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M15-2413     Document Type: Article
Times cited : (41)

References (27)
  • 1
    • 0032585233 scopus 로고    scopus 로고
    • Trials: The next 50 years. Large scale randomised evidence of moderate benefits
    • Editorial,PMID: 9794846
    • Peto R, Baigent C. Trials: The next 50 years. Large scale randomised evidence of moderate benefits [Editorial]. BMJ. 1998;317: 1170-1. [PMID: 9794846].
    • (1998) BMJ , vol.317 , pp. 1170-1171
    • Peto, R.1    Baigent, C.2
  • 3
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • PMID: 2702835
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1-10. [PMID: 2702835].
    • (1989) Control Clin Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 4
    • 84939864059 scopus 로고    scopus 로고
    • Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations
    • PMID: 26287849
    • Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, et al. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015;373:726-36. [PMID: 26287849] doi:10.1056/NEJMoa1502309.
    • (2015) N Engl J Med. , vol.373 , pp. 726-736
    • Hyman, D.M.1    Puzanov, I.2    Subbiah, V.3    Faris, J.E.4    Chau, I.5    Blay, J.Y.6
  • 5
    • 84904211802 scopus 로고    scopus 로고
    • Molecular analysis for therapy choice: NCI MATCH [Editorial]
    • PMID: 25023344
    • Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH [Editorial]. Semin Oncol. 2014;41:297-9. [PMID: 25023344] doi:10.1053/j.seminoncol.2014.05.002.
    • (2014) Semin Oncol. , vol.41 , pp. 297-299
    • Conley, B.A.1    Doroshow, J.H.2
  • 6
    • 84978682921 scopus 로고    scopus 로고
    • Group mentality: Determining if targeted treatments really work for cancer
    • PMID: 26937611
    • Chakradhar S. Group mentality: determining if targeted treatments really work for cancer. Nat Med. 2016;22:222-4. [PMID: 26937611] doi:10.1038/nm0316-222.
    • (2016) Nat Med. , vol.22 , pp. 222-224
    • Chakradhar, S.1
  • 7
    • 67650345287 scopus 로고    scopus 로고
    • Multiple histology phase II trials
    • PMID: 19549777
    • Leblanc M, Rankin C, Crowley J. Multiple histology phase II trials. Clin Cancer Res. 2009;15:4256-62. [PMID: 19549777] doi:10.1158/1078-0432.CCR-08-2069.
    • (2009) Clin Cancer Res. , vol.15 , pp. 4256-4262
    • Leblanc, M.1    Rankin, C.2    Crowley, J.3
  • 8
    • 0037445360 scopus 로고    scopus 로고
    • Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes
    • PMID: 12587104
    • Thall PF, Wathen JK, Bekele BN, Champlin RE, Baker LH, Benjamin RS. Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes. Stat Med. 2003;22:763-80. [PMID: 12587104].
    • (2003) Stat Med. , vol.22 , pp. 763-780
    • Thall, P.F.1    Wathen, J.K.2    Bekele, B.N.3    Champlin, R.E.4    Baker, L.H.5    Benjamin, R.S.6
  • 9
    • 84875133582 scopus 로고    scopus 로고
    • Borrowing information across subgroups in phase II trials: Is it useful?
    • PMID: 23303215
    • Freidlin B, Korn EL. Borrowing information across subgroups in phase II trials: is it useful? Clin Cancer Res. 2013;19:1326-34. [PMID: 23303215] doi:10.1158/1078-0432.CCR-12-1223.
    • (2013) Clin Cancer Res. , vol.19 , pp. 1326-1334
    • Freidlin, B.1    Korn, E.L.2
  • 10
    • 84960348344 scopus 로고    scopus 로고
    • The Bayesian basket design for genomic variant-driven phase II trials
    • PMID: 26970120
    • Simon R, Geyer S, Subramanian J, Roychowdhury S. The Bayesian basket design for genomic variant-driven phase II trials. Semin Oncol. 2016;43:13-8. [PMID: 26970120] doi:10.1053/j.seminoncol.2016.01.002.
    • (2016) Semin Oncol. , vol.43 , pp. 13-18
    • Simon, R.1    Geyer, S.2    Subramanian, J.3    Roychowdhury, S.4
  • 11
    • 84925377660 scopus 로고    scopus 로고
    • Application of molecular profiling in clinical trials for advanced metastatic cancers
    • PMID: 25663694
    • Kummar S, Williams PM, Lih CJ, Polley EC, Chen AP, Rubinstein LV, et al. Application of molecular profiling in clinical trials for advanced metastatic cancers. J Natl Cancer Inst. 2015;107. [PMID: 25663694] doi:10.1093/jnci/djv003.
    • (2015) J Natl Cancer Inst. , vol.107
    • Kummar, S.1    Williams, P.M.2    Lih, C.J.3    Polley, E.C.4    Chen, A.P.5    Rubinstein, L.V.6
  • 12
    • 84954026435 scopus 로고    scopus 로고
    • Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): A multicentre, open-label, proof-ofconcept, randomised, controlled phase 2 trial
    • SHIVA investigators, [PMID: 26342236]
    • Le Tourneau, C, Delord JP, Gonçalves A, Gavoille C, Dubot C, Isambert N, et al; SHIVA investigators. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): A multicentre, open-label, proof-ofconcept, randomised, controlled phase 2 trial. Lancet Oncol. 2015; 16:1324-34. [PMID: 26342236] doi:10.1016/S1470-2045(15)00188-6.
    • (2015) Lancet Oncol. , vol.16 , pp. 1324-1334
    • Delord, J.P.1    Gonçalves, A.2    Gavoille, C.3    Dubot, C.4    Isambert, N.5    Le Tourneau, C.6
  • 13
    • 84880206315 scopus 로고    scopus 로고
    • Clinical trials for precision oncology using next generation sequencing
    • Simon R, Polley E. Clinical trials for precision oncology using next generation sequencing. Per Med. 2013;10:485-95.
    • (2013) Per Med. , vol.10 , pp. 485-495
    • Simon, R.1    Polley, E.2
  • 15
    • 78650339993 scopus 로고    scopus 로고
    • Outcome- Adaptive randomization: Is it useful?
    • PMID: 21172882
    • Korn EL, Freidlin B. Outcome- Adaptive randomization: is it useful? J Clin Oncol. 2011;29:771-6. [PMID: 21172882] doi:10.1200/JCO.2010.31.1423.
    • (2011) J Clin Oncol. , vol.29 , pp. 771-776
    • Korn, E.L.1    Freidlin, B.2
  • 16
    • 0032844121 scopus 로고    scopus 로고
    • Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer
    • Herceptin Multinational Investigator Study Group., [PMID: 10482196
    • Shak S. Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer. Herceptin Multinational Investigator Study Group. Semin Oncol. 1999;26:71-7. [PMID: 10482196].
    • (1999) Semin Oncol. , vol.26 , pp. 71-77
    • Shak, S.1
  • 17
    • 84868481873 scopus 로고    scopus 로고
    • Vemurafenib: The first drug approved for BRAF-mutant cancer
    • PMID: 23060265
    • Bollag G, Tsai J, Zhang J, Zhang C, Ibrahim P, Nolop K, et al. Vemurafenib: The first drug approved for BRAF-mutant cancer. Nat Rev Drug Discov. 2012;11:873-86. [PMID: 23060265] doi:10.1038/nrd3847.
    • (2012) Nat Rev Drug Discov. , vol.11 , pp. 873-886
    • Bollag, G.1    Tsai, J.2    Zhang, J.3    Zhang, C.4    Ibrahim, P.5    Nolop, K.6
  • 18
    • 84939575246 scopus 로고    scopus 로고
    • Therapeutic targeting of anaplastic lymphoma kinase in lung cancer: A paradigm for precision cancer medicine
    • PMID: 25979929
    • Katayama R, Lovly CM, Shaw AT. Therapeutic targeting of anaplastic lymphoma kinase in lung cancer: A paradigm for precision cancer medicine. Clin Cancer Res. 2015;21:2227-35. [PMID: 25979929] doi:10.1158/1078-0432.CCR-14-2791.
    • (2015) Clin Cancer Res. , vol.21 , pp. 2227-2235
    • Katayama, R.1    Lovly, C.M.2    Shaw, A.T.3
  • 19
    • 0020974571 scopus 로고
    • Sample-size formula for the proportionalhazards regression model
    • PMID: 6354290
    • Schoenfeld DA. Sample-size formula for the proportionalhazards regression model. Biometrics. 1983;39:499-503. [PMID: 6354290].
    • (1983) Biometrics , vol.39 , pp. 499-503
    • Schoenfeld, D.A.1
  • 20
    • 6044278144 scopus 로고    scopus 로고
    • Evaluating the efficiency of targeted designs for randomized clinical trials
    • PMID: 15501951
    • Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res. 2004;10: 6759-63. [PMID: 15501951].
    • (2004) Clin Cancer Res. , vol.10 , pp. 6759-6763
    • Simon, R.1    Maitournam, A.2
  • 21
    • 84927606243 scopus 로고    scopus 로고
    • Lung Master Protocol (Lung-MAP)- A biomarkerdriven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400
    • PMID: 25680375
    • Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, et al. Lung Master Protocol (Lung-MAP)- A biomarkerdriven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res. 2015;21: 1514-24. [PMID: 25680375] doi:10.1158/1078-0432.CCR-13-3473.
    • (2015) Clin Cancer Res. , vol.21 , pp. 1514-1524
    • Herbst, R.S.1    Gandara, D.R.2    Hirsch, F.R.3    Redman, M.W.4    LeBlanc, M.5    Mack, P.C.6
  • 22
    • 85018221048 scopus 로고    scopus 로고
    • Improving clinical trial efficiency: Thinking outside the box
    • PMID: 25993165
    • Mandrekar SJ, Dahlberg SE, Simon R. Improving clinical trial efficiency: Thinking outside the box. Am Soc Clin Oncol Educ Book. 2015:141-7. [PMID: 25993165] doi:10.14694/EdBook-AM.2015.35.e141.
    • (2015) Am Soc Clin Oncol Educ Book , pp. 141-147
    • Mandrekar, S.J.1    Dahlberg, S.E.2    Simon, R.3
  • 23
    • 84932126124 scopus 로고    scopus 로고
    • ALCHEMIST: Bringing genomic discovery and targeted therapies to early-stage lung cancer
    • PMID: 25677079
    • Gerber DE, Oxnard GR, Govindan R. ALCHEMIST: Bringing genomic discovery and targeted therapies to early-stage lung cancer. Clin Pharmacol Ther. 2015;97:447-50. [PMID: 25677079] doi:10.1002/cpt.91.
    • (2015) Clin Pharmacol Ther. , vol.97 , pp. 447-450
    • Gerber, D.E.1    Oxnard, G.R.2    Govindan, R.3
  • 24
    • 85018231159 scopus 로고    scopus 로고
    • Changing the paradigm-multistage multiarm randomized trials and stratified cancer medicine [Editorial]
    • S-CORT Consortium., [PMID: 26070918
    • Lawler M, Kaplan R, Wilson RH, Maughan T; S-CORT Consortium. Changing the paradigm-multistage multiarm randomized trials and stratified cancer medicine [Editorial]. Oncologist. 2015;20: 849-51. [PMID: 26070918] doi:10.1634/theoncologist.2015-0014.
    • (2015) Oncologist , vol.20 , pp. 849-851
    • Lawler, M.1    Kaplan, R.2    Wilson, R.H.3    Maughan, T.4
  • 25
    • 84877278637 scopus 로고    scopus 로고
    • Implementing personalized cancer genomics in clinical trials
    • PMID: 23629504
    • Simon R, Roychowdhury S. Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov. 2013;12:358-69. [PMID: 23629504] doi:10.1038/nrd3979.
    • (2013) Nat Rev Drug Discov. , vol.12 , pp. 358-369
    • Simon, R.1    Roychowdhury, S.2
  • 26
    • 79959795786 scopus 로고    scopus 로고
    • Improved survival with vemurafenib in melanoma with BRAF V600E mutation
    • BRIM-3 Study Group., [PMID: 21639808]
    • Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507-16. [PMID: 21639808] doi:10.1056/NEJMoa1103782.
    • (2011) N Engl J Med. , vol.364 , pp. 2507-2516
    • Chapman, P.B.1    Hauschild, A.2    Robert, C.3    Haanen, J.B.4    Ascierto, P.5    Larkin, J.6
  • 27
    • 84918804764 scopus 로고    scopus 로고
    • First-line crizotinib versus chemotherapy in ALK-positive lung cancer
    • PROFILE 1014 Investigators., [PMID: 25470694
    • Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, et al; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371:2167- 77. [PMID: 25470694] doi:10.1056/NEJMoa1408440.
    • (2014) N Engl J Med. , vol.371 , pp. 2167-2177
    • Solomon, B.J.1    Mok, T.2    Kim, D.W.3    Wu, Y.L.4    Nakagawa, K.5    Mekhail, T.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.