Phase II clinical trials in oncology: are we hitting the target?
The number of novel and molecularly targeted agents in the last decade that need screening for preliminary efficacy in Phase II trials has increased. Many of these agents have a cytostatic mode of action that is difficult to assess using traditional Phase II designs. These new agents require detailed evaluation to optimize their dosing, to evaluate their effects on their target and to define early markers that predict for a definitive benefit. This review focuses on the options for Phase II trial designs. The different end points, single versus multiarm and randomized designs, the use of biomarkers and Bayesian approaches are also reviewed. The final design chosen will depend on the characteristics and circumstances of each individual study.
Ang
Mei-Kim
MK
National Cancer Centre Singapore, 11 Hospital Drive, Singapore. ang.mei.kim@nccs.com.sg
Tan
Say-Beng
SB
Lim
Wan-Teck
WT
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D001499:Bayes Theorem; D014408:Biomarkers, Tumor / Q000032:analysis; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D016503:Drug Delivery Systems; D023381:Endpoint Determination; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor