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Volumn 9, Issue 2, 2012, Pages 141-154

Clinical trial designs for testing biomarker-based personalized therapies

Author keywords

[No Author keywords available]

Indexed keywords

BEXAROTENE; BIOLOGICAL MARKER; DOCETAXEL; DOXORUBICIN; ERLOTINIB; SORAFENIB; TOPOTECAN; VANDETANIB;

EID: 84861814820     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774512437252     Document Type: Article
Times cited : (24)

References (38)
  • 1
    • 6044278144 scopus 로고    scopus 로고
    • Evaluating the efficiency of targeted designs for randomized clinical trials
    • Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res. 2004 ; 10: 6759-63
    • (2004) Clin Cancer Res , vol.10 , pp. 6759-6763
    • Simon, R.1    Maitournam, A.2
  • 2
    • 35348814333 scopus 로고    scopus 로고
    • Development and validation of biomarker classifiers for treatment selection
    • Simon R. Development and validation of biomarker classifiers for treatment selection. J Stat Plan Infer. 2008 ; 138: 308-20
    • (2008) J Stat Plan Infer , vol.138 , pp. 308-320
    • Simon, R.1
  • 3
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers: Design issues
    • Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: Design issues. J Natl Cancer I. 2010 ; 102: 152-60
    • (2010) J Natl Cancer i , vol.102 , pp. 152-160
    • Freidlin, B.1    McShane, L.M.2    Korn, E.L.3
  • 4
    • 34548096927 scopus 로고    scopus 로고
    • A prospective randomized controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician's choice in patients with recurrent platinum-resistant ovarian cancer
    • Cree IA, Kurbacher CM, Lamont A, et al. A prospective randomized controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician's choice in patients with recurrent platinum-resistant ovarian cancer. Anti-Cancer Drug. 2007 ; 18: 1093-101
    • (2007) Anti-Cancer Drug , vol.18 , pp. 1093-1101
    • Cree, I.A.1    Kurbacher, C.M.2    Lamont, A.3
  • 5
    • 74049098972 scopus 로고    scopus 로고
    • Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology
    • Simon R. Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Pers Med. 2010 ; 7: 33-47
    • (2010) Pers Med , vol.7 , pp. 33-47
    • Simon, R.1
  • 6
    • 78649923786 scopus 로고    scopus 로고
    • Predictive biomarker validation in practice: Lessons from real trials
    • Mandrekar SJ, Sargent DJ. Predictive biomarker validation in practice: Lessons from real trials. Clin Trials. 2010 ; 7: 567-73
    • (2010) Clin Trials , vol.7 , pp. 567-573
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 7
    • 52649154223 scopus 로고    scopus 로고
    • Bayesian adaptive design for targeted therapy development in lung cancer-A step toward personalized medicine
    • Zhou X, Liu S, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer-A step toward personalized medicine. Clin Trials. 2008 ; 5: 181-93
    • (2008) Clin Trials , vol.5 , pp. 181-193
    • Zhou, X.1    Liu, S.2    Kim, E.S.3    Herbst, R.S.4    Lee, J.J.5
  • 8
    • 78649956851 scopus 로고    scopus 로고
    • Bayesian adaptive randomization designs for targeted agent development
    • Lee JJ, Gu X, Liu S. Bayesian adaptive randomization designs for targeted agent development. Clin Trials. 2010 ; 7: 584-96
    • (2010) Clin Trials , vol.7 , pp. 584-596
    • Lee, J.J.1    Gu, X.2    Liu, S.3
  • 9
    • 79957857433 scopus 로고    scopus 로고
    • The BATTLE trial: Personalizing therapy for lung cancer
    • Kim ES, Herbst RS, Wistuba II. The BATTLE trial: Personalizing therapy for lung cancer. et al Cancer Disc. 2011 ; 1: 44-51
    • (2011) Et Al Cancer Disc , vol.1 , pp. 44-51
    • Kim, E.S.1    Herbst, R.S.2    Wistuba, I.I.3
  • 10
    • 67650652432 scopus 로고    scopus 로고
    • I-SPY2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
    • Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther. 2009 ; 86: 97-100
    • (2009) Clin Pharmacol Ther , vol.86 , pp. 97-100
    • Barker, A.D.1    Sigman, C.C.2    Kelloff, G.J.3
  • 11
    • 9944253001 scopus 로고    scopus 로고
    • A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer
    • Berkenblit A, Seiden MV, Matulonis UA, et al. A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer. Gynecol Oncol. 2004 ; 95: 624-31
    • (2004) Gynecol Oncol , vol.95 , pp. 624-631
    • Berkenblit, A.1    Seiden, M.V.2    Matulonis, U.A.3
  • 12
    • 45949104460 scopus 로고    scopus 로고
    • New therapies for ovarian cancer: Cytotoxics and molecularly targeted agents
    • Dinh P, Harnett P, Piccart-Gebhart MJ, Awada A. New therapies for ovarian cancer: Cytotoxics and molecularly targeted agents. Crit Rev Oncol Hemat. 2008 ; 67: 103-12
    • (2008) Crit Rev Oncol Hemat , vol.67 , pp. 103-112
    • Dinh, P.1    Harnett, P.2    Piccart-Gebhart, M.J.3    Awada, A.4
  • 13
    • 0035879099 scopus 로고    scopus 로고
    • Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan
    • Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001 ; 19: 3312-22
    • (2001) J Clin Oncol , vol.19 , pp. 3312-3322
    • Gordon, A.N.1    Fleagle, J.T.2    Guthrie, D.3
  • 14
    • 1842477895 scopus 로고    scopus 로고
    • Expression of multidrug resistance-1 protein inversely correlates with paclitaxel response and survival in ovarian cancer patients: A study in serial samples
    • Penson RT, Oliva E, Skates SJ, et al. Expression of multidrug resistance-1 protein inversely correlates with paclitaxel response and survival in ovarian cancer patients: A study in serial samples. Gynecol Oncol. 2004 ; 93: 98-106
    • (2004) Gynecol Oncol , vol.93 , pp. 98-106
    • Penson, R.T.1    Oliva, E.2    Skates, S.J.3
  • 15
    • 0037331627 scopus 로고    scopus 로고
    • A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: A Gynecologic Oncology Group study
    • Rose PG, Blessing JA, Ball HG, et al. A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: A Gynecologic Oncology Group study. Gynecol Oncol. 2003 ; 88: 130-35
    • (2003) Gynecol Oncol , vol.88 , pp. 130-135
    • Rose, P.G.1    Blessing, J.A.2    Ball, H.G.3
  • 16
    • 63949083698 scopus 로고    scopus 로고
    • Topoisomerase IIalpha mRNA and protein expression in ovarian carcinoma: Correlation with clinicopathological factors and prognosis
    • Faggad A, Darb-Esfahani S, Wirtz R, et al. Topoisomerase IIalpha mRNA and protein expression in ovarian carcinoma: Correlation with clinicopathological factors and prognosis. Modern Pathol. 2009 ; 22: 579-88
    • (2009) Modern Pathol , vol.22 , pp. 579-588
    • Faggad, A.1    Darb-Esfahani, S.2    Wirtz, R.3
  • 17
    • 44949133943 scopus 로고    scopus 로고
    • Prognostic role of topoisomerase-IIalpha in advanced ovarian cancer patients
    • Ferrandina G, Petrillo M, Carbone A, et al. Prognostic role of topoisomerase-IIalpha in advanced ovarian cancer patients. Brit J Cancer. 2008 ; 98: 1910-15
    • (2008) Brit J Cancer , vol.98 , pp. 1910-1915
    • Ferrandina, G.1    Petrillo, M.2    Carbone, A.3
  • 18
    • 0034053339 scopus 로고    scopus 로고
    • P-glycoprotein expression is a marker for chemotherapy resistance and prognosis in advanced ovarian cancer
    • Baekelandt MM, Holm R, Nesland JM, Trope CG, Kristensen GB. P-glycoprotein expression is a marker for chemotherapy resistance and prognosis in advanced ovarian cancer. Anticancer Res. 2000 ; 20: 1061-67
    • (2000) Anticancer Res , vol.20 , pp. 1061-1067
    • Baekelandt, M.M.1    Holm, R.2    Nesland, J.M.3    Trope, C.G.4    Kristensen, G.B.5
  • 19
    • 0030995629 scopus 로고    scopus 로고
    • P-glycoprotein as a prognostic indicator in pre- and postchemotherapy ovarian adenocarcinoma
    • Khalifa MA, Abdoh AA, Mannel RS, et al. P-glycoprotein as a prognostic indicator in pre- and postchemotherapy ovarian adenocarcinoma. Int J Gynecol Pathol. 1997 ; 16: 69-75
    • (1997) Int J Gynecol Pathol , vol.16 , pp. 69-75
    • Khalifa, M.A.1    Abdoh, A.A.2    Mannel, R.S.3
  • 20
    • 45749127481 scopus 로고    scopus 로고
    • Predictive biomarkers of chemotherapy efficacy in colorectal cancer: Results from the UK MRC FOCUS trial
    • Braun MS, Richman SD, Quirke P, et al. Predictive biomarkers of chemotherapy efficacy in colorectal cancer: Results from the UK MRC FOCUS trial. J Clin Oncol. 2008 ; 26: 2690-98
    • (2008) J Clin Oncol , vol.26 , pp. 2690-2698
    • Braun, M.S.1    Richman, S.D.2    Quirke, P.3
  • 21
    • 0031978169 scopus 로고    scopus 로고
    • DNA-topoisomerase i activity and content in epithelial ovarian cancer
    • Codegoni AM, Castagna S, Mangioni C, et al. DNA-topoisomerase I activity and content in epithelial ovarian cancer. Ann Oncol. 1998 ; 9: 313-19
    • (1998) Ann Oncol , vol.9 , pp. 313-319
    • Codegoni, A.M.1    Castagna, S.2    Mangioni, C.3
  • 22
    • 0041820227 scopus 로고    scopus 로고
    • Expression of class III beta-tubulin reduces microtubule assembly and confers resistance to paclitaxel
    • Hari M, Yang H, Zeng C, Canizales M, Cabral F. Expression of class III beta-tubulin reduces microtubule assembly and confers resistance to paclitaxel. Cell Motil Cytoskel. 2003 ; 56: 45-56
    • (2003) Cell Motil Cytoskel , vol.56 , pp. 45-56
    • Hari, M.1    Yang, H.2    Zeng, C.3    Canizales, M.4    Cabral, F.5
  • 23
    • 0030661729 scopus 로고    scopus 로고
    • Immunohistochemical detection of DNA topoisomerase i in formalin fixed, paraffin wax embedded normal tissues and in ovarian carcinomas
    • Holden JA, Rahn MP, Jolles CJ, Vorobyev SV, Bronstein IB. Immunohistochemical detection of DNA topoisomerase I in formalin fixed, paraffin wax embedded normal tissues and in ovarian carcinomas. Mol Pathol. 1997 ; 50: 247-53
    • (1997) Mol Pathol , vol.50 , pp. 247-253
    • Holden, J.A.1    Rahn, M.P.2    Jolles, C.J.3    Vorobyev, S.V.4    Bronstein, I.B.5
  • 24
    • 0030931827 scopus 로고    scopus 로고
    • Taxol-resistant epithelial ovarian tumors are associated with altered expression of specific beta-tubulin isotypes
    • Kavallaris M, Kuo DY, Burkhart CA, et al. Taxol-resistant epithelial ovarian tumors are associated with altered expression of specific beta-tubulin isotypes. J Clin Invest. 1997 ; 100: 1282-93
    • (1997) J Clin Invest , vol.100 , pp. 1282-1293
    • Kavallaris, M.1    Kuo, D.Y.2    Burkhart, C.A.3
  • 25
    • 0035009052 scopus 로고    scopus 로고
    • Correlation between Topo II alpha expression and chemosensitivity testing for Topo II-targeting drugs in gynaecological carcinomas
    • Koshiyama M, Fujii H, Kinezaki M, Yoshida M. Correlation between Topo II alpha expression and chemosensitivity testing for Topo II-targeting drugs in gynaecological carcinomas. Anticancer Res. 2001 ; 21: 905-10
    • (2001) Anticancer Res , vol.21 , pp. 905-910
    • Koshiyama, M.1    Fujii, H.2    Kinezaki, M.3    Yoshida, M.4
  • 26
    • 19944430079 scopus 로고    scopus 로고
    • Class III beta-tubulin overexpression is a prominent mechanism of paclitaxel resistance in ovarian cancer patients
    • Mozzetti S, Ferlini C, Concolino P, et al. Class III beta-tubulin overexpression is a prominent mechanism of paclitaxel resistance in ovarian cancer patients. Clin Cancer Res. 2005 ; 11: 298-305
    • (2005) Clin Cancer Res , vol.11 , pp. 298-305
    • Mozzetti, S.1    Ferlini, C.2    Concolino, P.3
  • 27
    • 10744220410 scopus 로고    scopus 로고
    • Gene expression patterns in ovarian carcinomas
    • Schaner ME, Ross DT, Ciaravino G, et al. Gene expression patterns in ovarian carcinomas. Mol Biol Cell. 2003 ; 14: 4376-86
    • (2003) Mol Biol Cell , vol.14 , pp. 4376-4386
    • Schaner, M.E.1    Ross, D.T.2    Ciaravino, G.3
  • 28
    • 52649085237 scopus 로고    scopus 로고
    • Novel molecular subtypes of serous and endometrioid ovarian cancer linked to clinical outcome
    • Tothill RW, Tinker AV, George J, et al. Novel molecular subtypes of serous and endometrioid ovarian cancer linked to clinical outcome. Clin Cancer Res. 2008 ; 14: 5198-208
    • (2008) Clin Cancer Res , vol.14 , pp. 5198-5208
    • Tothill, R.W.1    Tinker, A.V.2    George, J.3
  • 29
    • 78649932251 scopus 로고    scopus 로고
    • A threshold sample-enrichment approach in a clinical trial with heterogenous subpopulations
    • Liu A, Liu C, Li Q, Yu KF, Yuan VW. A threshold sample-enrichment approach in a clinical trial with heterogenous subpopulations. Clin Trials. 2010 ; 7: 537-45
    • (2010) Clin Trials , vol.7 , pp. 537-545
    • Liu, A.1    Liu, C.2    Li, Q.3    Yu, K.F.4    Yuan, V.W.5
  • 30
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 ; 10: 1-10
    • (1989) Control Clin Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 31
    • 33645465945 scopus 로고    scopus 로고
    • Power, sample size and adaptation considerations in the design of group sequential clinical trials
    • Lai TL, Shih MC. Power, sample size and adaptation considerations in the design of group sequential clinical trials. Biometrika. 2004 ; 91: 507-28
    • (2004) Biometrika , vol.91 , pp. 507-528
    • Lai, T.L.1    Shih, M.C.2
  • 33
    • 84972528712 scopus 로고
    • Saddlepoint methods and statistical inference
    • Reid N. Saddlepoint methods and statistical inference. Stat Sci. 1988 ; 23: 213-27
    • (1988) Stat Sci , vol.23 , pp. 213-227
    • Reid, N.1
  • 34
    • 84861835856 scopus 로고    scopus 로고
    • Clinical drug tests adapted for speed
    • Ledford H. Clinical drug tests adapted for speed. Nature. 2010 1258 ; 464 :
    • (2010) Nature , vol.1258 , pp. 464
    • Ledford, H.1
  • 35
    • 77953053344 scopus 로고    scopus 로고
    • A simulation study for comparing testing statistics in response-adaptive randomization
    • Gu X, Lee J. A simulation study for comparing testing statistics in response-adaptive randomization. BMC Med Res Methodol. 2010 ; 10: 48
    • (2010) BMC Med Res Methodol , vol.10 , pp. 48
    • Gu, X.1    Lee, J.2
  • 36
    • 78650339993 scopus 로고    scopus 로고
    • Outcome-adaptive randomization: Is it useful?
    • Korn EL, Freidlin B. Outcome-adaptive randomization: Is it useful?. J Clin Oncol. 2011 ; 29: 771-76
    • (2011) J Clin Oncol , vol.29 , pp. 771-776
    • Korn, E.L.1    Freidlin, B.2
  • 37
    • 34047192414 scopus 로고    scopus 로고
    • A comparison of adaptive allocation rules for group-sequential binary response clinical trials
    • Morgan CC, Coad SD. A comparison of adaptive allocation rules for group-sequential binary response clinical trials. Stat Med. 2007 ; 26: 1937-54
    • (2007) Stat Med , vol.26 , pp. 1937-1954
    • Morgan, C.C.1    Coad, S.D.2
  • 38
    • 79952079839 scopus 로고    scopus 로고
    • Adaptive clinical trials: The promise and the caution
    • Berry DA. Adaptive clinical trials: The promise and the caution. J Clin Oncol. 2010 ; 29: 606-09
    • (2010) J Clin Oncol , vol.29 , pp. 606-609
    • Berry, D.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.