Phase I Cancer Clinical Trials: A Practical Guide

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule, and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment.

In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials usually measure adverse effects rather than
the molecular target or anti-tumor effects. These factors render the design, conduct, analysis, and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in
understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials


Author: Elizabeth A. Eisenhauer
Publisher: Oxford University Press, USA
Published: 04/17/2015
Pages: 368
Binding Type: Paperback
Weight: 1.14lbs
Size: 9.10h x 6.10w x 0.90d
ISBN: 9780199359011

About the Author

EAE: Head, Department of Oncology, Queen's University, Medical Director, Oncology Program, Kingston General Hospital, Cancer Centre of Southeastern Ontario, Kingston, Canada; CT: Professor of Clinical Pharmacology and Oncology, Head, Section of Clinical Cancer Research Groups, Leeds Institute of Cancer Studies and Pathology, St. James's Institute of Oncology Leeds, UK; MB: Founder and Chairman, International Drug Development Institute, Louvain-la-Neuve, Belgium, Associate Professor of Biostatistics, Universiteit Hasselt Diepenbeek, Belgium

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