메뉴 건너뛰기




Volumn 823, Issue , 2012, Pages 19-34

Clinical trial design in the age of molecular profiling

Author keywords

Biomarkers; Clinical trial; Design; End points; Imaging; Pharmacodynamics; Tumor

Indexed keywords

ANIMAL; ARTICLE; CLINICAL TRIAL (TOPIC); GENE EXPRESSION PROFILING; GENE EXPRESSION REGULATION; GENETICS; HUMAN; METHODOLOGY; MOLECULARLY TARGETED THERAPY; NEOPLASM; SIGNAL TRANSDUCTION;

EID: 82355181790     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-60327-216-2_2     Document Type: Article
Times cited : (3)

References (47)
  • 1
    • 47749118439 scopus 로고    scopus 로고
    • Endpoints for assessing drug activity in clinical trials
    • Pazdur, R. (2008) Endpoints for assessing drug activity in clinical trials. Oncologist 13 Suppl 2, 19-21.
    • (2008) Oncologist , vol.13 , Issue.SUPPL. 2 , pp. 19-21
    • Pazdur, R.1
  • 2
    • 33747874014 scopus 로고    scopus 로고
    • Alternative clinical end points in rectal cancer - Are we getting closer?
    • DOI 10.1093/annonc/mdl173
    • Glynne-Jones, R., Mawdsley, S., Pearce, T., Buyse, M. (2006) Alternative clinical end points in rectal cancer-are we getting closer? Ann Oncol 17, 1239-48. (Pubitemid 44288215)
    • (2006) Annals of Oncology , vol.17 , Issue.8 , pp. 1239-1248
    • Glynne-Jones, R.1    Mawdsley, S.2    Pearce, T.3    Buyse, M.4
  • 3
    • 47749119646 scopus 로고    scopus 로고
    • Selection of response criteria for clinical trials of sarcoma treatment
    • Schuetze, S. M., Baker, L. H., Benjamin, R. S., Canetta, R. (2008) Selection of response criteria for clinical trials of sarcoma treatment. Oncologist 13 Suppl 2, 32-40.
    • (2008) Oncologist , vol.13 , Issue.SUPPL. 2 , pp. 32-40
    • Schuetze, S.M.1    Baker, L.H.2    Benjamin, R.S.3    Canetta, R.4
  • 4
    • 82355185570 scopus 로고    scopus 로고
    • Regulatory approvals for oncology products based on accelerated clinical development and limited data packages-2
    • Scott, J., McGettigan, G. (2005) Regulatory approvals for oncology products based on accelerated clinical development and limited data packages-2. Regulatory Rapporteur 2, 6-15.
    • (2005) Regulatory Rapporteur , vol.2 , pp. 6-15
    • Scott, J.1    McGettigan, G.2
  • 5
    • 0034594628 scopus 로고    scopus 로고
    • 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
    • Therasse, P., Arbuck, S. G., Eisenhauer, E. A., Wanders, J., Kaplan, R. S., Rubinstein, L. et al. (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. J Natl Cancer Inst 92, 205-16.
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3    Wanders, J.4    Kaplan, R.S.5    Rubinstein, L.6
  • 7
    • 79956053386 scopus 로고    scopus 로고
    • Advanced hepatocellular carcinoma. Review of targeted molecular drugs
    • Alves, R. C., Alves, D., Guz, B., Matos, C., Viana, M., Harriz, M. et al. (2011) Advanced hepatocellular carcinoma. Review of targeted molecular drugs. Ann Hepatol 10, 21-7.
    • (2011) Ann Hepatol , vol.10 , pp. 21-27
    • Alves, R.C.1    Alves, D.2    Guz, B.3    Matos, C.4    Viana, M.5    Harriz, M.6
  • 9
    • 57849117384 scopus 로고    scopus 로고
    • New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
    • Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R. et al. (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45, 228-47.
    • (2009) Eur J Cancer , vol.45 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3    Schwartz, L.H.4    Sargent, D.5    Ford, R.6
  • 10
    • 43749121858 scopus 로고    scopus 로고
    • Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: Initial results from the National Oncologic PET Registry
    • Hillner, B. E., Siegel, B. A., Liu, D., Shields, A. F., Gareen, I. F., Hanna, L. et al. (2008) Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: initial results from the National Oncologic PET Registry. J Clin Oncol 26, 2155-61.
    • (2008) J Clin Oncol , vol.26 , pp. 2155-2161
    • Hillner, B.E.1    Siegel, B.A.2    Liu, D.3    Shields, A.F.4    Gareen, I.F.5    Hanna, L.6
  • 11
    • 23844456531 scopus 로고    scopus 로고
    • Expanding the use of magnetic resonance in the assessment of tumor response to therapy: Workshop report
    • DOI 10.1158/0008-5472.CAN-05-0674
    • Evelhoch, J., Garwood, M., Vigneron, D., Knopp, M., Sullivan, D., Menkens, A. et al. (2005) Expanding the use of magnetic resonance in the assessment of tumor response to therapy: workshop report. Cancer Res 65, 7041-4. (Pubitemid 41161229)
    • (2005) Cancer Research , vol.65 , Issue.16 , pp. 7041-7044
    • Evelhoch, J.1    Garwood, M.2    Vigneron, D.3    Knopp, M.4    Sullivan, D.5    Menkens, A.6    Clarke, L.7    Liu, G.8
  • 13
    • 84892358740 scopus 로고    scopus 로고
    • Emerging molecular therapies: Drugs interfering with signal transduction pathways
    • (Bronchud, M. H., Foote, M., Giaccone, G., Olopade, O., and Workman, P., ed.), Humana Press, Totowa, NJ
    • Reid, A. H., Baird, R., Workman, P. (2008) Emerging molecular therapies: Drugs interfering with signal transduction pathways, in Principles of Molecular Oncology (Bronchud, M. H., Foote, M., Giaccone, G., Olopade, O., and Workman, P., ed.), Humana Press, Totowa, NJ, pp. 325-329.
    • (2008) Principles of Molecular Oncology , pp. 325-329
    • Reid, A.H.1    Baird, R.2    Workman, P.3
  • 14
    • 79551520680 scopus 로고    scopus 로고
    • A phase III randomized trial of gemcitabineoxaliplatin versus carboplatin-paclitaxel as fi rstline therapy in patients with advanced non-small cell lung cancer
    • Weissman, C. H., Reynolds, C. H., Neubauer, M. A., Pritchard, S., Kobina, S., Asmar, L. (2011) A phase III randomized trial of gemcitabineoxaliplatin versus carboplatin-paclitaxel as fi rstline therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol 6, 358-64.
    • (2011) J Thorac Oncol , vol.6 , pp. 358-364
    • Weissman, C.H.1    Reynolds, C.H.2    Neubauer, M.A.3    Pritchard, S.4    Kobina, S.5    Asmar, L.6
  • 15
    • 33746205373 scopus 로고    scopus 로고
    • Clinical trials design and treatment tailoring: General principles applied to breast cancer research
    • DOI 10.1016/j.critrevonc.2005.11.003, PII S1040842805002271
    • Therasse, P., Carbonnelle, S., Bogaerts, J. (2006) Clinical trials design and treatment tailoring: general principles applied to breast cancer research. Crit Rev Oncol Hematol 59, 98-105. (Pubitemid 44094104)
    • (2006) Critical Reviews in Oncology/Hematology , vol.59 , Issue.2 , pp. 98-105
    • Therasse, P.1    Carbonnelle, S.2    Bogaerts, J.3
  • 16
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges
    • Mandrekar, S. J., Sargent, D. J. (2009) Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 27, 4027-34.
    • (2009) J Clin Oncol , vol.27 , pp. 4027-4034
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 17
    • 78649923786 scopus 로고    scopus 로고
    • Predictive biomarker validation in practice: Lessons from real trials
    • Mandrekar, S. J., Sargent, D. J. (2010) Predictive biomarker validation in practice: lessons from real trials. Clin Trials 7, 567-73.
    • (2010) Clin Trials , vol.7 , pp. 567-573
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 18
    • 49049089802 scopus 로고    scopus 로고
    • Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer
    • Scagliotti, G. V., Parikh, P., von Pawel, J., Biesma, B., Vansteenkiste, J., Manegold, C. et al. (2008) Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26, 3543-51.
    • (2008) J Clin Oncol , vol.26 , pp. 3543-3551
    • Scagliotti, G.V.1    Parikh, P.2    Von Pawel, J.3    Biesma, B.4    Vansteenkiste, J.5    Manegold, C.6
  • 23
    • 33750895236 scopus 로고    scopus 로고
    • TAILORx: Trial Assigning Individualized Options for Treatment (Rx)
    • Sparano, J. A. (2006) TAILORx: trial assigning individualized options for treatment (Rx). Clin Breast Cancer 7, 347-50. (Pubitemid 44717771)
    • (2006) Clinical Breast Cancer , vol.7 , Issue.4 , pp. 347-350
    • Sparano, J.A.1
  • 24
    • 39149113165 scopus 로고    scopus 로고
    • Development of the 21-gene assay and its application in clinical practice and clinical trials
    • DOI 10.1200/JCO.2007.15.1068
    • Sparano, J. A., Paik, S. (2008) Development of the 21-gene assay and its application in clinical practice and clinical trials. J Clin Oncol 26, 721-8. (Pubitemid 351264384)
    • (2008) Journal of Clinical Oncology , vol.26 , Issue.5 , pp. 721-728
    • Sparano, J.A.1    Paik, S.2
  • 25
    • 78649646316 scopus 로고    scopus 로고
    • Breast cancer assessment tools and optimizing adjuvant therapy
    • Oakman, C., Santarpia, L., Di Leo, A. (2010) Breast cancer assessment tools and optimizing adjuvant therapy. Nat Rev Clin Oncol 7, 725-32.
    • (2010) Nat Rev Clin Oncol , vol.7 , pp. 725-732
    • Oakman, C.1    Santarpia, L.2    Di Leo, A.3
  • 26
    • 45749157664 scopus 로고    scopus 로고
    • Commercialized multigene predictors of clinical outcome for breast cancer
    • DOI 10.1634/theoncologist.2007-0248
    • Ross, J. S., Hatzis, C., Symmans, W. F., Pusztai, L., Hortobagyi, G. N. (2008) Commercialized multigene predictors of clinical outcome for breast cancer. Oncologist 13, 477-93. (Pubitemid 351872866)
    • (2008) Oncologist , vol.13 , Issue.5 , pp. 477-493
    • Ross, J.S.1    Hatzis, C.2    Symmans, W.F.3    Pusztai, L.4    Hortobagyi, G.N.5
  • 29
    • 79953243501 scopus 로고    scopus 로고
    • Implementing prognostic and predictive biomarkers in CRC clinical trials
    • doi: 10.1038/nrclinonc.2011.15
    • Schaeybroeck, S. V., Allen, W. L., Turkington, R. C., Johnston, P. G. (2011) Implementing prognostic and predictive biomarkers in CRC clinical trials. Nat Rev Clin Oncol doi: 10.1038/nrclinonc.2011.15
    • (2011) Nat Rev Clin Oncol
    • Schaeybroeck, S.V.1    Allen, W.L.2    Turkington, R.C.3    Johnston, P.G.4
  • 30
    • 0033048939 scopus 로고    scopus 로고
    • Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system
    • Jacobs, T. W., Gown, A. M., Yaziji, H., Barnes, M. J., Schnitt, S. J. (1999) Specifi city of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. J Clin Oncol 17, 1983-7. (Pubitemid 29318825)
    • (1999) Journal of Clinical Oncology , vol.17 , Issue.7 , pp. 1983-1987
    • Jacobs, T.W.1    Gown, A.M.2    Yaziji, H.3    Barnes, M.J.4    Schnitt, S.J.5
  • 31
    • 1542503725 scopus 로고    scopus 로고
    • HER-2 testing and trastuzumab therapy for metastatic breast cancer: A cost-effectiveness analysis
    • DOI 10.1200/JCO.2004.04.158
    • Elkin, E. B., Weinstein, M. C., Winer, E. P., Kuntz, K. M., Schnitt, S. J., Weeks, J. C. (2004) HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 22, 854-63. (Pubitemid 41103597)
    • (2004) Journal of Clinical Oncology , vol.22 , Issue.5 , pp. 854-863
    • Elkin, E.B.1    Weinstein, M.C.2    Winer, E.P.3    Kuntz, K.M.4    Schnitt, S.J.5    Weeks, J.C.6
  • 33
    • 0032895235 scopus 로고    scopus 로고
    • Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer
    • DOI 10.1016/S0149-2918(00)88288-0
    • Goldenberg, M. M. (1999) Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer. Clin Ther 21, 309-18. (Pubitemid 29157789)
    • (1999) Clinical Therapeutics , vol.21 , Issue.2 , pp. 309-318
    • Goldenberg, M.M.1
  • 37
    • 0029991439 scopus 로고    scopus 로고
    • Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer
    • Baselga, J., Tripathy, D., Mendelsohn, J., Baughman, S., Benz, C. C., Dantis, L. et al. (1996) Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 14, 737-44.
    • (1996) J Clin Oncol , vol.14 , pp. 737-744
    • Baselga, J.1    Tripathy, D.2    Mendelsohn, J.3    Baughman, S.4    Benz, C.C.5    Dantis, L.6
  • 38
    • 0038666476 scopus 로고    scopus 로고
    • Clinical trial design and end points for epidermal growth factor receptor-targeted therapies: Implications for drug development and practice
    • Arteaga, C. L., Baselga, J. (2003) Clinical trial design and end points for epidermal growth factor receptor-targeted therapies: implications for drug development and practice. Clin Cancer Res 9, 1579-89. (Pubitemid 36554579)
    • (2003) Clinical Cancer Research , vol.9 , Issue.5 , pp. 1579-1589
    • Arteaga, C.L.1    Baselga, J.2
  • 40
    • 40849147041 scopus 로고    scopus 로고
    • EGFR antagonists in cancer treatment
    • Ciardiello, F., Tortora, G. (2008) EGFR antagonists in cancer treatment. N Engl J Med 358, 1160-74.
    • (2008) N Engl J Med , vol.358 , pp. 1160-1174
    • Ciardiello, F.1    Tortora, G.2
  • 43
    • 42649145667 scopus 로고    scopus 로고
    • Wild-type KRAS is required for panitumumab effi cacy in patients with metastatic colorectal cancer
    • Amado, R. G., Wolf, M., Peeters, M., Van Cutsem, E., Siena, S., Freeman, D. J. et al. (2008) Wild-type KRAS is required for panitumumab effi cacy in patients with metastatic colorectal cancer. J Clin Oncol 26, 1626-34.
    • (2008) J Clin Oncol , vol.26 , pp. 1626-1634
    • Amado, R.G.1    Wolf, M.2    Peeters, M.3    Van Cutsem, E.4    Siena, S.5    Freeman, D.J.6
  • 46
    • 45149084723 scopus 로고    scopus 로고
    • First-line gefi tinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations
    • Sequist, L. V., Martins, R. G., Spigel, D., Grunberg, S. M., Spira, A., Janne, P. A. et al. (2008) First-line gefi tinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 26, 2442-9.
    • (2008) J Clin Oncol , vol.26 , pp. 2442-2449
    • Sequist, L.V.1    Martins, R.G.2    Spigel, D.3    Grunberg, S.M.4    Spira, A.5    Janne, P.A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.