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)

被引：63

作者：

Booth, Christopher M. ^{[1
]}

Calvert, A. Hilary ^{[2
]}

Giaccone, Giuseppe ^{[3
]}

Lobbezoo, Marinus W. ^{[4
]}

Seymour, Lesley K. ^{[1
]}

Eisenhauer, Elizabeth A. ^{[1
]}

机构：

[1] Canada Clin Trials Grp, Natl Canc Inst, Kingston, ON K7L 3N6, Canada

[2] Med Sch Newcastle Upon Tyne, No Inst Canc Res, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England

[3] NCI, Med Oncol Branch, Bethesda, MD 20892 USA

[4] NDDO Res Fdn, Amsterdam, Netherlands

来源：

EUROPEAN JOURNAL OF CANCER | 2008年 / 44卷 / 01期

关键词：

clinical trials/phase I; drug therapy; neoplasms; receptors; growth factors/antagonists and inhibitors;

D O I：

10.1016/j.ejca.2007.07.034

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

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. (c) 2007 Elsevier Ltd. All rights reserved.

引用

页码：19 / 24

页数：6

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