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Volumn 21, Issue 20, 2015, Pages 4545-4551

Expansion cohorts in first-in-human solid tumor oncology trials

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; IPILIMUMAB; PEMBROLIZUMAB; PLACEBO; NEW DRUG;

EID: 84945542507     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-3244     Document Type: Article
Times cited : (30)

References (14)
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  • 2
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    • Genomic medicine frontier in human solid tumors: Prospects and challenges
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    • Dienstmann, R.1    Rodon, J.2    Barretina, J.3    Tabernero, J.4
  • 3
    • 84880706152 scopus 로고    scopus 로고
    • Oncology meets immunology: The cancer-immunity cycle
    • Chen SD, Melman I. Oncology meets immunology: the cancer-immunity cycle. Immunity 2013;39:1-10.
    • (2013) Immunity , vol.39 , pp. 1-10
    • Chen, S.D.1    Melman, I.2
  • 5
    • 84945560955 scopus 로고    scopus 로고
    • [PDF on the Internet]. Geneva (Switzerland): The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); [cited 2015 Aug 12]. Available from
    • ICHharmonised tripartite guideline: general considerations for clinical trials (E8) [PDF on the Internet]. Geneva (Switzerland): The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); 1997 [cited 2015 Aug 12]. Available from: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E8/Step4/E8-Guideline.pdf.
    • (1997) ICHharmonised Tripartite Guideline: General Considerations for Clinical Trials (E8)
  • 6
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    • Temple R. Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials. Am Heart J 2000;139: S133-5.
    • (2000) Am Heart J , vol.139 , pp. S133-S135
    • Temple, R.1
  • 8
    • 84905216493 scopus 로고    scopus 로고
    • Evaluation of statistical designs in phase i expansion cohorts: The Dana-Farber/Harvard Cancer Center experience
    • Dahlberg SE, Shapiro GI, Clark JW, Johnson BE. Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience. J Natl Cancer Inst 2014;106:1-7.
    • (2014) J Natl Cancer Inst , vol.106 , pp. 1-7
    • Dahlberg, S.E.1    Shapiro, G.I.2    Clark, J.W.3    Johnson, B.E.4
  • 9
    • 84904006604 scopus 로고    scopus 로고
    • [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; [cited 2015 Aug 12]. Available from
    • Guidance for industry: expedited programs for serious conditions-drugs and biologics [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014 [cited 2015 Aug 12]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.
    • (2014) Guidance for Industry: Expedited Programs for Serious Conditions-drugs and Biologics
  • 10
    • 84945579041 scopus 로고    scopus 로고
    • Good review practice: Management of Breakthrough Therapy-designated drugs and biologics
    • [PDF on the Internet] Silver Spring (MD): U.S. Food and Drug Administration, Office of New Drugs; [cited 2015 Aug 1]. Available from
    • Good review practice: management of Breakthrough Therapy-designated drugs and biologics [PDF on the Internet]. In: Manual of policies and procedure, Center forDrug Evaluation and Research (MAPP6025.6). Silver Spring (MD): U.S. Food and Drug Administration, Office of New Drugs; 2014 [cited 2015 Aug 1]. Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407009.pdf.
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    • Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, et al. Antiprogrammed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014;384:1109-17.
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    • Drugs@FDA [database on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014[cited 2015Aug 1]. Summary review; reference ID: 3621254 [about 22 p.]. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/125514Orig1s000SumR.pdf. Files updated daily.
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.