메뉴 건너뛰기




Volumn 20, Issue 2, 2014, Pages 281-288

Predictive value of phase i trials for safety in later trials and final approved dose: Analysis of 61 approved cancer drugs

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 84892690026     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-2103     Document Type: Article
Times cited : (43)

References (21)
  • 1
    • 0031016857 scopus 로고    scopus 로고
    • Critical role of phase 1 clinical trials in cancer treatment
    • American Society of Clinical Oncology
    • Critical role of phase 1 clinical trials in cancer treatment. American Society of Clinical Oncology. J Clin Oncol. 1997;15:853-9.
    • (1997) J Clin Oncol. , vol.15 , pp. 853-859
  • 2
    • 79955617684 scopus 로고    scopus 로고
    • Phase 1 trials of molecularly targeted agents: Should we pay more attention to late toxicities?
    • Postel-Vinay S, Gomez-Roca C, Molife LR, Anghan B, Levy A, Judson 1, et al. Phase I trials of molecularly targeted agents: should we pay more attention to late toxicities? J Clin Oncol. 2011;29: 1728-35.
    • (2011) J Clin Oncol , vol.29 , pp. 1728-1735
    • Postel-Vinay, S.1    Gomez-Roca, C.2    Molife, L.R.3    Anghan, B.4    Levy, A.5    Judson, I.6
  • 3
    • 79958774831 scopus 로고    scopus 로고
    • Phase 1 trials of molecular targeted therapies: Are we evaluating toxicities properly?
    • Soria JC. Phase 1 trials of molecular targeted therapies: are we evaluating toxicities properly? Eur J Cancer. 2011;47:1443-5.
    • (2011) Eur J Cancer. , vol.47 , pp. 1443-1445
    • Soria, J.C.1
  • 4
    • 84856032420 scopus 로고    scopus 로고
    • Nature and subjectivity of dose-limiting toxicities in contemporary phase 1 trials: Comparison of cytotoxic versus non-cytotoxic drugs
    • Penel N, Adenis A, Clisant S, Bonneterre J. Nature and subjectivity of dose-limiting toxicities in contemporary phase 1 trials: comparison of cytotoxic versus non-cytotoxic drugs. Invest New Drugs. 2011;29: 1414-9.
    • (2011) Invest New Drugs , vol.29 , pp. 1414-1419
    • Penel, N.1    Adenis, A.2    Clisant, S.3    Bonneterre, J.4
  • 5
    • 84866914428 scopus 로고    scopus 로고
    • The impact of nondrug-related toxicities on the estimation of the maximum tolerated dose in phase 1 trials
    • Iasonos A, Gounder M, Spriggs DR, Gerecitano JF, Hyman DM, Zohar S, et al. The impact of nondrug-related toxicities on the estimation of the maximum tolerated dose in phase I trials. Clin Cancer Res. 2012;18:5179-87.
    • (2012) Clin Cancer Res. , vol.18 , pp. 5179-5187
    • Iasonos, A.1    Gounder, M.2    Spriggs, D.R.3    Gerecitano, J.F.4    Hyman, D.M.5    Zohar, S.6
  • 6
    • 79958777006 scopus 로고    scopus 로고
    • Heterogeneity in the definition of dose-limiting toxicity in phase 1 cancer clinical trials of molecularly targeted agents: A review of the literature
    • Le Tourneau C, Razak AR, Gan HK, Pop S, Dieras V, Tresca P, et al.Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: A review of the literature. Eur J Cancer. 2011;47:1468-75.
    • (2011) Eur J Cancer. , vol.47 , pp. 1468-1475
    • Le Tourneau, C.1    Razak, A.R.2    Gan, H.K.3    Pop, S.4    Dieras, V.5    Tresca, P.6
  • 7
    • 72449133295 scopus 로고    scopus 로고
    • Administration UFaD, Available from:
    • Administration UFaD. FDA approved drug products. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
    • FDA Approved Drug Products
  • 8
    • 65549149873 scopus 로고    scopus 로고
    • Clinical benefit in phase I trials of novel molecularly targeted agents: Does dose matter?
    • Postel-Vinay S, Arkenau HT, Olmos D, Ang J, Barriuso J, Ashley S, et al. Clinical benefit in phase I trials of novel molecularly targeted agents: does dose matter? Br J Cancer. 2009;100:1373-8.
    • (2009) Br J Cancer. , vol.100 , pp. 1373-1378
    • Postel-Vinay, S.1    Arkenau, H.T.2    Olmos, D.3    Ang, J.4    Barriuso, J.5    Ashley, S.6
  • 9
    • 33748652419 scopus 로고    scopus 로고
    • What is the right dose? The elusive optimal biologic dose in phase 1 clinical trials
    • Adjei AA. What is the right dose? The elusive optimal biologic dose in phase 1 clinical trials. J Clin Oncol. 2006;24:4054-5.
    • (2006) J Clin Oncol. , vol.24 , pp. 4054-4055
    • Adjei, A.A.1
  • 10
    • 43249124980 scopus 로고    scopus 로고
    • Dose selection in phase 1 studies: Why we should always go for the top
    • Sleijfer S, Wiemer E. Dose selection in phase I studies: why we should always go for the top. J Clin Oncol. 2008;26:1576-8.
    • (2008) J Clin Oncol. , vol.26 , pp. 1576-1578
    • Sleijfer, S.1    Wiemer, E.2
  • 11
    • 76749161498 scopus 로고    scopus 로고
    • Phase 1 oncology studies: Evidence that in the era of targeted therapies patients on lower doses do not fare worse
    • Jain RK, Lee JJ, Hong D, Markman M, Gong J, Naing A, et al. Phase 1 oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clin Cancer Res. 2010;16: 1289-97.
    • (2010) Clin Cancer Res. , vol.16 , pp. 1289-1297
    • Jain, R.K.1    Lee, J.J.2    Hong, D.3    Markman, M.4    Gong, J.5    Naing, A.6
  • 12
    • 66849118694 scopus 로고    scopus 로고
    • Dose escalation methods in phase 1 cancer clinical trials
    • Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009;101:708-20.
    • (2009) J Natl Cancer Inst. , vol.101 , pp. 708-720
    • Le Tourneau, C.1    Lee, J.J.2    Siu, L.L.3
  • 13
    • 3242679103 scopus 로고    scopus 로고
    • Phase 1 trial design for solid tumor studies of targeted, non-cytotoxic agents: Theory and practice
    • Parulekar WR, Eisenhauer EA. Phase 1 trial design for solid tumor studies of targeted, non-cytotoxic agents: Theory and practice. J Natl Cancer Inst. 2004;96:990-7.
    • (2004) J Natl Cancer Inst. , vol.96 , pp. 990-997
    • Parulekar, W.R.1    Eisenhauer, E.A.2
  • 14
    • 84865165918 scopus 로고    scopus 로고
    • The price we pay for progress: A meta-analysis of harms of newly approved anticancer drugs
    • Niraula S, Seruga B, Ocana A, Shao T, Goldstein R, Tannock IF, et al. The price we pay for progress: A meta-analysis of harms of newly approved anticancer drugs. J Clin Oncol. 2012;30:3012-9.
    • (2012) J Clin Oncol. , vol.30 , pp. 3012-3019
    • Niraula, S.1    Seruga, B.2    Ocana, A.3    Shao, T.4    Goldstein, R.5    Tannock, I.F.6
  • 16
    • 7244243743 scopus 로고    scopus 로고
    • Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials
    • Roberts TG Jr, Goulart BH, Squitieri L, Stallings SC, Halpern EF, Chabner BA, et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA. 2004;292: 2130-40.
    • (2004) JAMA , vol.292 , pp. 2130-2140
    • Roberts, Jr.T.G.1    Goulart, B.H.2    Squitieri, L.3    Stallings, S.C.4    Halpern, E.F.5    Chabner, B.A.6
  • 17
    • 84857055503 scopus 로고    scopus 로고
    • Patient selection for oncology phase I trials: A multiinstitutional study of prognostic factors
    • Olmos D, A'Hern R P, Marsoni S, Morales R, Gomez-Roca C, Verweij J, et al. Patient selection for oncology phase I trials: A multiinstitutional study of prognostic factors. J Clin Oncol. 2012;30: 996-1004.
    • (2012) J Clin Oncol. , vol.30 , pp. 996-1004
    • Olmos, D.1    A'Hern, R.P.2    Marsoni, S.3    Morales, R.4    Gomez-Roca, C.5    Verweij, J.6
  • 18
    • 84856071989 scopus 로고    scopus 로고
    • A qualitative study evaluating causality attribution for serious adverse events during early-phase oncology clinical trials
    • Mukherjee SD, Coombes ME, Levine M, Cosby J, Kowaleski B, Arnold A. A qualitative study evaluating causality attribution for serious adverse events during early-phase oncology clinical trials. Invest New Drugs. 2011;29:1013-20.
    • (2011) Invest New Drugs. , vol.29 , pp. 1013-1020
    • Mukherjee, S.D.1    Coombes, M.E.2    Levine, M.3    Cosby, J.4    Kowaleski, B.5    Arnold, A.6
  • 19
    • 77950505295 scopus 로고    scopus 로고
    • Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials
    • Le Tourneau C, Stathis A, Vidal L, Moore MJ, Siu LL. Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials. J Clin Oncol. 2010;28:1401-7.
    • (2010) J Clin Oncol. , vol.28 , pp. 1401-1407
    • Le Tourneau, C.1    Stathis, A.2    Vidal, L.3    Moore, M.J.4    Siu, L.L.5
  • 20
    • 0036843156 scopus 로고    scopus 로고
    • The multifunctional multiinstitutional and sometimes even global phase 1 study: A better life for phase 1 evaluations or just "living large"?
    • Tolcher AW, Takimoto CH, Rowinsky EK. The multifunctional, multiinstitutional, and sometimes even global phase I study: A better life for phase I evaluations or just "living large"? J Clin Oncol. 2002; 20:4276-8.
    • (2002) J Clin Oncol. , vol.20 , pp. 4276-4278
    • Tolcher, A.W.1    Takimoto, C.H.2    Rowinsky, E.K.3
  • 21
    • 37149030424 scopus 로고    scopus 로고
    • Endpoints and other considerations in phase 1 studies of targeted anticancer therapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT)
    • Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Seymour LK, Eisenhauer EA. Endpoints and other considerations in phase I studies of targeted anticancer therapy: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). Eur J Cancer. 2008;44:19-24.
    • (2008) Eur J Cancer. , vol.44 , pp. 19-24
    • Booth, C.M.1    Calvert, A.H.2    Giaccone, G.3    Lobbezoo, M.W.4    Seymour, L.K.5    Eisenhauer, E.A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.