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)
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- 作者：Christopher M. Booth ; A. Hilary Calvert ; Giuseppe Giaccone ; Marinus W. Lobbezoo ; Lesley K. Seymour ; Elizabeth A. Eisenhauer
- 关键词：Clinical trials/phase I ; Drug therapy ; Neoplasms ; Receptors ; growth factors/antagonists and inhibitors
- 刊名：European Journal of Cancer
- 出版年：2008
- 出版时间：January 2008
- 年：2008
- 卷：44
- 期：1
- 页码：19-24
- 全文大小：151 K
文摘
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.