title: Phase II clinical trials in oncology: are we hitting the target?
abstract: 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.
authors.affiliation: National Cancer Centre Singapore, 11 Hospital Drive, Singapore. ang.mei.kim@nccs.com.sg
authors.forename: Mei-Kim
authors.initials: MK
authors.lastname: Ang
authors.forename: Say-Beng
authors.initials: SB
authors.lastname: Tan
authors.forename: Wan-Teck
authors.initials: WT
authors.lastname: Lim
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor