title: 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).
abstract: Oncology drug development has seen a paradigm shift in the past decade from traditional cytotoxic agents to molecular targeted therapies. Given the different mechanisms and toxicities of these agents, drug development methodology may also require novel approaches. To address emerging issues in oncology drug development the 'Methodology for the Development of Innovative Cancer Therapies' (MDICT) task force was established to provide a forum for academic leaders involved in cancer drug development to discuss methodological issues inherent to the study of targeted anticancer therapy. At the inaugural MDICT meeting in 2006, discussion focused on the most appropriate primary endpoints for first-in-man phase I studies of targeted anticancer agents and organisational issues of such studies. This report summarises the scientific reviews and discussions as well as the recommendations regarding phase I trial design formulated by the MDICT task force.
authors: National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada.
authors: Christopher M
authors: CM
authors: Booth
authors: A Hilary
authors: AH
authors: Calvert
authors: Giuseppe
authors: G
authors: Giaccone
authors: Marinus W
authors: MW
authors: Lobbezoo
authors: Lesley K
authors: LK
authors: Seymour
authors: Elizabeth A
authors: EA
authors: Eisenhauer
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D015195:Drug Design; D006287:Health Planning Guidelines; D006801:Humans; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D035703:Therapies, Investigational
chemical_list: D000970:Antineoplastic Agents