TY - JOUR
T1 - Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?
AU - Carden, Craig P.
AU - Sarker, Debashis
AU - Postel-Vinay, Sophie
AU - Yap, Timothy A.
AU - Attard, Gerthardt
AU - Banerji, Udai
AU - Garrett, Michelle D.
AU - Thomas, George V.
AU - Workman, Paul
AU - Kaye, Stan B.
AU - de Bono, Johann S.
PY - 2010/2/1
Y1 - 2010/2/1
N2 - Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
AB - Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
UR - http://www.scopus.com/inward/record.url?scp=75149113069&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2009.11.006
DO - 10.1016/j.drudis.2009.11.006
M3 - Review article
C2 - 19961955
AN - SCOPUS:75149113069
SN - 1359-6446
VL - 15
SP - 88
EP - 97
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 3-4
ER -