Phase 1 Cancer Clinical Trials: A Practical Guide by Elizabeth A EisenhauerPhase 1 Cancer Clinical Trials: A Practical Guide by Elizabeth A Eisenhauer

Phase 1 Cancer Clinical Trials: A Practical Guide

byElizabeth A Eisenhauer, Christopher Twelves, Marc Buyse

Paperback | July 26, 2006

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Phase I trials are a critical first step in the study of novel therapeutic approaches. They follow years of development in the laboratory, and precede Phase II and III trials where testing of the drug becomes more focused yet is conducted on a wider scale. The primary goals of Phase I trials are to identify the recommended dose, schedule and pharmacologic behaviour of new agents or new combinations of agents, and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. In general, because of thenature of the effects of treatment, most studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures of adverse effects, but increasingly investigators are interested in assessment of the effects ofnew drugs on their molecular target. These factors render the design, conduct, analysis and ethical aspects of Phase I cancer clinical trials unique. This book provides a practical guide to Phase I cancer trials and is appropriate for oncology trainees or specialists interested in understanding cancer drug development. Topics covered include preclinical requirements needed for first-in-man investigation of new agents, principles and statisticaldesign, ethical considerations of Phase I studies, pharmacokinetics, pharmacodynamics, and studies in special populations. Practical information on protocol development, study activation and conduct, as well as how to write reports of the results, are incorporated. Numerous appendices offer documenttemplates to use in Phase I study development, and examples from actual Phase I trials are interspersed throughout, making this a true 'hands-on' guide. In an exciting time in cancer research, as the number and type of new potential anti-cancer drugs is increasing dramatically, this book provides much needed information on the first stage in getting a drug approved.
Elizabeth Eisenhauer was appointed to the Board of Directors of the National Cancer Institute of Canada in 2002, and will become President in June 2006. Through her work with the IND program and NCIC CTG, she has co-ordinated over 170 Phase I, II and III trials carried out across Canada, the US and Europe. Marc Buyse founded the Inte...
Title:Phase 1 Cancer Clinical Trials: A Practical GuideFormat:PaperbackDimensions:360 pages, 9.21 × 6.14 × 0.81 inPublished:July 26, 2006Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0198567197

ISBN - 13:9780198567196

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Table of Contents

1. Elizabeth A Eisenhauer: Introduction2. Elizabeth A Eisenhauer: Preclinical data and requirements3. Elizabeth A Eisenhauer: Basics of Phase I Design: first-in-man studies4. Elizabeth A Eisenhauer: Ethical issues in Phase I Cancer Trials5. Christopher Twelves: Phase I Trials in special populations6. Marc Buyse: Statistical designs for Phase I Trials7. Elizabeth A Eisenhauer: Writing the protocol8. Elizabeth A Eisenhauer: Before you begin9. Christopher Twelves: Practical aspects of pharmacokinetics and pharmacodynamics10. Elizabeth A Eisenhauer: Running the study11. Elizabeth A Eisenhauer: Reporting and interpreting resultsAppendices