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Volumn 88, Issue 1, 2013, Pages 144-153

Design of oncology clinical trials: A review

Author keywords

II and III oncology clinical trials; Phases I; PK PD modeling; Safety and efficacy endpoints; Statistical analyses; Trial designs

Indexed keywords

ANTINEOPLASTIC AGENT; IMATINIB; NILOTINIB; TRASTUZUMAB;

EID: 84884160745     PISSN: 10408428     EISSN: 18790461     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2013.03.007     Document Type: Review
Times cited : (16)

References (42)
  • 1
    • 0034614637 scopus 로고    scopus 로고
    • The hallmarks of cancer
    • January (1), [Review]
    • Hanahan D., Weinberg R.A. The hallmarks of cancer. Cell 2000, 100(January (1)):57-70. [Review].
    • (2000) Cell , vol.100 , pp. 57-70
    • Hanahan, D.1    Weinberg, R.A.2
  • 3
    • 84864367909 scopus 로고    scopus 로고
    • Global cancer transitions according to the Human Development Index (2008-2030): a population-based study
    • August (8)
    • Bray F., Jemal A., Grey N., et al. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncology 2012, 13(August (8)):790-801.
    • (2012) Lancet Oncology , vol.13 , pp. 790-801
    • Bray, F.1    Jemal, A.2    Grey, N.3
  • 4
    • 84871595073 scopus 로고    scopus 로고
    • Staroslawska Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy
    • January (1)
    • Awada A., Dirix L., Manso Sanchez L., et al. Staroslawska Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy. Annals of Oncology 2013, 24(January (1)):109-116.
    • (2013) Annals of Oncology , vol.24 , pp. 109-116
    • Awada, A.1    Dirix, L.2    Manso Sanchez, L.3
  • 5
    • 84868520609 scopus 로고    scopus 로고
    • Trastuzumab emtansine for HER2-positive advanced breast cancer
    • October, [Epub ahead of print]
    • Verma S., Miles D., Gianni L., et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. New England Journal of Medicine 2012, (October). [Epub ahead of print].
    • (2012) New England Journal of Medicine
    • Verma, S.1    Miles, D.2    Gianni, L.3
  • 6
    • 80054092983 scopus 로고    scopus 로고
    • Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer
    • [Review], October (20)
    • LoRusso P.M., Weiss D., Guardino E., et al. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clinical Cancer Research 2011, 17(October (20)):6437-6447. [Review].
    • (2011) Clinical Cancer Research , vol.17 , pp. 6437-6447
    • LoRusso, P.M.1    Weiss, D.2    Guardino, E.3
  • 7
    • 79955832182 scopus 로고    scopus 로고
    • Trastuzumab emtansine: a novel antibody-drug conjugate for HER2-positive breast cancer
    • June (6)
    • Burris H.A. Trastuzumab emtansine: a novel antibody-drug conjugate for HER2-positive breast cancer. Expert Opinion on Biological Therapy 2011, 11(June (6)):807-819.
    • (2011) Expert Opinion on Biological Therapy , vol.11 , pp. 807-819
    • Burris, H.A.1
  • 8
    • 79952201536 scopus 로고    scopus 로고
    • Development of anti-cancer drugs
    • [Review], October (53)
    • Arrondeau J., Gan H.K., Razak A.R., et al. Development of anti-cancer drugs. Discovery Medicine 2010, 10(October (53)):355-362. [Review].
    • (2010) Discovery Medicine , vol.10 , pp. 355-362
    • Arrondeau, J.1    Gan, H.K.2    Razak, A.R.3
  • 9
    • 38949111031 scopus 로고    scopus 로고
    • A review of phase 2-3 clinical trial designs
    • [Epub Review 2007 September 2], March (1)
    • Thall P.F. A review of phase 2-3 clinical trial designs. Lifetime Data Analysis 2008, 14(March (1)):37-53. [Epub Review 2007 September 2].
    • (2008) Lifetime Data Analysis , vol.14 , pp. 37-53
    • Thall, P.F.1
  • 10
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts
    • August (4)
    • Bretz F., Schmidli H., König F., et al. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal 2006, 48(August (4)):623-634.
    • (2006) Biometrical Journal , vol.48 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    König, F.3
  • 11
    • 33748533820 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations
    • August (4)
    • Schmidli H., Bretz F., Racine A., et al. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations. Biometrical Journal 2006, 48(August (4)):635-643.
    • (2006) Biometrical Journal , vol.48 , pp. 635-643
    • Schmidli, H.1    Bretz, F.2    Racine, A.3
  • 12
    • 0033523233 scopus 로고    scopus 로고
    • Anticancer agents targeting signaling molecules and cancer cell environment: challenges for drug development?
    • [Review], August (15)
    • Gelmon K.A., Eisenhauer E.A., Harris A.L., et al. Anticancer agents targeting signaling molecules and cancer cell environment: challenges for drug development?. Journal of the National Cancer Institute 1999, 91(August (15)):1281-1287. [Review].
    • (1999) Journal of the National Cancer Institute , vol.91 , pp. 1281-1287
    • Gelmon, K.A.1    Eisenhauer, E.A.2    Harris, A.L.3
  • 14
    • 0030833783 scopus 로고    scopus 로고
    • From mouse to man: the early clinical testings
    • Perry K. From mouse to man: the early clinical testings. Drug Information Journal 1997, 31:729-736.
    • (1997) Drug Information Journal , vol.31 , pp. 729-736
    • Perry, K.1
  • 16
    • 0030749549 scopus 로고    scopus 로고
    • Accelerated titration designs for phase I clinical trials in oncology
    • August (15)
    • Simon R., Freidlin B., Rubinstein L., et al. Accelerated titration designs for phase I clinical trials in oncology. Journal of the National Cancer Institute 1997, 89(August (15)):1138-1147.
    • (1997) Journal of the National Cancer Institute , vol.89 , pp. 1138-1147
    • Simon, R.1    Freidlin, B.2    Rubinstein, L.3
  • 17
    • 70450273499 scopus 로고    scopus 로고
    • Classical 3+3 design" versus "accelerated titration designs": analysis of 270 phase 1 trials investigating anti-cancer agents
    • December (6)
    • Penel N., Isambert N., Leblond P., et al. Classical 3+3 design" versus "accelerated titration designs": analysis of 270 phase 1 trials investigating anti-cancer agents. Investigational New Drugs 2009, 27(December (6)):552-556.
    • (2009) Investigational New Drugs , vol.27 , pp. 552-556
    • Penel, N.1    Isambert, N.2    Leblond, P.3
  • 18
    • 77949699034 scopus 로고    scopus 로고
    • Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee
    • March (6)
    • Ivy S.P., Siu L.L., Garrett-Mayer E., et al. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clinical Cancer Research 2010, 16(March (6)):1726-1736.
    • (2010) Clinical Cancer Research , vol.16 , pp. 1726-1736
    • Ivy, S.P.1    Siu, L.L.2    Garrett-Mayer, E.3
  • 19
    • 0035884462 scopus 로고    scopus 로고
    • The continual reassessment method and its applications: a Bayesian methodology for phase I cancer clinical trials
    • September (17/18)
    • Ishizuka N., Ohashi Y. The continual reassessment method and its applications: a Bayesian methodology for phase I cancer clinical trials. Statistics in Medicine 2001, 20(September (17/18)):2661-2681.
    • (2001) Statistics in Medicine , vol.20 , pp. 2661-2681
    • Ishizuka, N.1    Ohashi, Y.2
  • 20
    • 33745236089 scopus 로고    scopus 로고
    • Using the continual reassessment method: lessons learned from an EORTC phase I dose finding study
    • July (10)
    • Paoletti X., Baron B., Schöffski P., et al. Using the continual reassessment method: lessons learned from an EORTC phase I dose finding study. European Journal of Cancer 2006, 42(July (10)):1362-1368.
    • (2006) European Journal of Cancer , vol.42 , pp. 1362-1368
    • Paoletti, X.1    Baron, B.2    Schöffski, P.3
  • 21
    • 67651067881 scopus 로고    scopus 로고
    • A Bayesian case study in oncology Phase I combination dose-finding using logistic regression with covariates
    • Bailey S., Neuenschwander B., Laird G., et al. A Bayesian case study in oncology Phase I combination dose-finding using logistic regression with covariates. Journal of Biopharmaceutical Statistics 2009, 19(3):469-484.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , Issue.3 , pp. 469-484
    • Bailey, S.1    Neuenschwander, B.2    Laird, G.3
  • 22
    • 33751584603 scopus 로고    scopus 로고
    • Adaptive dose selection using efficacy-toxicity trade-offs: illustrations and practical considerations
    • Thall P.F., Cook J.D., Estey E.H. Adaptive dose selection using efficacy-toxicity trade-offs: illustrations and practical considerations. Journal of Biopharmaceutical Statistics 2006, 16(5):623-638.
    • (2006) Journal of Biopharmaceutical Statistics , vol.16 , Issue.5 , pp. 623-638
    • Thall, P.F.1    Cook, J.D.2    Estey, E.H.3
  • 23
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-offs
    • September (3)
    • Thall P.F., Cook J.D. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004, 60(September (3)):684-693.
    • (2004) Biometrics , vol.60 , pp. 684-693
    • Thall, P.F.1    Cook, J.D.2
  • 24
    • 77954556925 scopus 로고    scopus 로고
    • Pharmacological modeling and biostatistical analysis of a new drug
    • April
    • Ananthakrishnan R., Gona P. Pharmacological modeling and biostatistical analysis of a new drug. Open Access Journal of Clinical Trials 2010, 2(April):59-82.
    • (2010) Open Access Journal of Clinical Trials , vol.2 , pp. 59-82
    • Ananthakrishnan, R.1    Gona, P.2
  • 26
    • 0029780751 scopus 로고    scopus 로고
    • Improved designs for dose escalation studies using pharmacokinetic measurements
    • August (15)
    • Piantadosi S., Liu G. Improved designs for dose escalation studies using pharmacokinetic measurements. Statistics in Medicine 1996, 15(August (15)):1605-1618.
    • (1996) Statistics in Medicine , vol.15 , pp. 1605-1618
    • Piantadosi, S.1    Liu, G.2
  • 27
    • 63449114216 scopus 로고    scopus 로고
    • Randomized phase II designs
    • [Epub Review 2009 March 10], March (6)
    • Rubinstein L., Crowley J., Ivy P., et al. Randomized phase II designs. Clinical Cancer Research 2009, 15(March (6)):1883-1890. [Epub Review 2009 March 10].
    • (2009) Clinical Cancer Research , vol.15 , pp. 1883-1890
    • Rubinstein, L.1    Crowley, J.2    Ivy, P.3
  • 28
    • 24944591389 scopus 로고    scopus 로고
    • One- and two-stage designs for stratified phase II clinical trials
    • September (17)
    • London W.B., Chang M.N. One- and two-stage designs for stratified phase II clinical trials. Statistics in Medicine 2005, 24(September (17)):2597-2611.
    • (2005) Statistics in Medicine , vol.24 , pp. 2597-2611
    • London, W.B.1    Chang, M.N.2
  • 29
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • March (1)
    • Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989, 10(March (1)):1-10.
    • (1989) Controlled Clinical Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 30
    • 0029591692 scopus 로고
    • Incorporating toxicity considerations into the design of two-stage phase II clinical trials
    • December (4)
    • Bryant J., Day R. Incorporating toxicity considerations into the design of two-stage phase II clinical trials. Biometrics 1995, 51(December (4)):1372-1383.
    • (1995) Biometrics , vol.51 , pp. 1372-1383
    • Bryant, J.1    Day, R.2
  • 31
    • 67651030311 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: one size does not fit all
    • Mandrekar S.J., Sargent D.J. Clinical trial designs for predictive biomarker validation: one size does not fit all. Journal of Biopharmaceutical Statistics 2009, 19(3):530-542.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , Issue.3 , pp. 530-542
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 32
    • 66349125688 scopus 로고    scopus 로고
    • Adaptive patient enrichment designs in therapeutic trials
    • April (2)
    • Wang S.J., Hung H.M., O'Neill R.T. Adaptive patient enrichment designs in therapeutic trials. Biometrical Journal 2009, 51(April (2)):358-374.
    • (2009) Biometrical Journal , vol.51 , pp. 358-374
    • Wang, S.J.1    Hung, H.M.2    O'Neill, R.T.3
  • 33
    • 79956157675 scopus 로고    scopus 로고
    • An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints
    • July-August (4)
    • Jenkins M., Stone A., Jennison C. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints. Pharmaceutical Statistics 2011, 10(July-August (4)):347-356.
    • (2011) Pharmaceutical Statistics , vol.10 , pp. 347-356
    • Jenkins, M.1    Stone, A.2    Jennison, C.3
  • 34
    • 63449108223 scopus 로고    scopus 로고
    • Effective incorporation of biomarkers into phase II trials
    • [Review], March (6)
    • McShane L.M., Hunsberger S., Adjei A.A. Effective incorporation of biomarkers into phase II trials. Clinical Cancer Research 2009, 15(March (6)):1898-1905. [Review].
    • (2009) Clinical Cancer Research , vol.15 , pp. 1898-1905
    • McShane, L.M.1    Hunsberger, S.2    Adjei, A.A.3
  • 35
    • 84864041947 scopus 로고    scopus 로고
    • Integration of cell biology, pharmacological modeling and statistical analysis. Part I. Cell biology and PK/PD in the oncology paradigm
    • August (2)
    • Ananthakrishnan R., Menon S. Integration of cell biology, pharmacological modeling and statistical analysis. Part I. Cell biology and PK/PD in the oncology paradigm. Critical Reviews in Oncology/Hematology 2012, 83(August (2)):153-169.
    • (2012) Critical Reviews in Oncology/Hematology , vol.83 , pp. 153-169
    • Ananthakrishnan, R.1    Menon, S.2
  • 36
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials - a review
    • [Review], May
    • Chow S.C., Chang M. Adaptive design methods in clinical trials - a review. Orphanet Journal of Rare Diseases 2008, 3(May):11. [Review].
    • (2008) Orphanet Journal of Rare Diseases , vol.3 , pp. 11
    • Chow, S.C.1    Chang, M.2
  • 37
    • 0034963267 scopus 로고    scopus 로고
    • Response evaluation criteria in solid tumors (RECIST): new guidelines
    • July (1)
    • Tsuchida Y., Therasse P. Response evaluation criteria in solid tumors (RECIST): new guidelines. Medical and Pediatric Oncology 2001, 37(July (1)):1-3.
    • (2001) Medical and Pediatric Oncology , vol.37 , pp. 1-3
    • Tsuchida, Y.1    Therasse, P.2
  • 38
    • 57849117384 scopus 로고    scopus 로고
    • New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
    • January (2)
    • Eisenhauer E.A., Therasse P., Bogaerts J., et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). European Journal of Cancer 2009, 45(January (2)):228-247.
    • (2009) European Journal of Cancer , vol.45 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3
  • 39
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • September (3)
    • O'Brien P.C., Fleming T.R. A multiple testing procedure for clinical trials. Biometrics 1979, 35(September (3)):549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 40
    • 0024832356 scopus 로고
    • Practical problems in interim analyses, with particular regard to estimation
    • December (Suppl. 4)
    • Pocock S.J., Hughes M.D. Practical problems in interim analyses, with particular regard to estimation. Controlled Clinical Trials 1989, 10(December (Suppl. 4)):209S-221S.
    • (1989) Controlled Clinical Trials , vol.10
    • Pocock, S.J.1    Hughes, M.D.2
  • 41
    • 0024270883 scopus 로고
    • Stopping rules and estimation problems in clinical trials
    • December (12)
    • Hughes M.D., Pocock S.J. Stopping rules and estimation problems in clinical trials. Statistics in Medicine 1988, 7(December (12)):1231-1242.
    • (1988) Statistics in Medicine , vol.7 , pp. 1231-1242
    • Hughes, M.D.1    Pocock, S.J.2
  • 42
    • 0023186839 scopus 로고
    • Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners
    • March (1)
    • Geller N.L., Pocock S.J. Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics 1987, 43(March (1)):213-223.
    • (1987) Biometrics , vol.43 , pp. 213-223
    • Geller, N.L.1    Pocock, S.J.2


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