Phase I Cancer Clinical Trials: A Practical Guide (2nd edition)

ISBN : 9780199359011

Elizabeth A. Eisenhauer; Christopher Twelves; Marc Buyse
368 ページ
156 x 234 mm

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 are usually measures adverse effects rather than 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


1. Introduction
2. Preclinical Data and Requirements
3. Phase 0 Clinical Trials
4. Basics of Phase I Design: First-in-man Studies
5. Ethical Issues in First-in-human Phase I Cancer Trials
6. Phase I Trials in Special Populations and Circumstances
7. Phase I Trials of Immunotherapeutics
8. Statistical Designs for First-in-human Phase I Trials
9. Writing the Protocol
10. Practical Aspects of Pharmacokinetics and Pharmacodynamics
11. Process, Pitfalls, and Logistics of Phase I Trials
12. Reporting and Interpreting Results
Appendix: Useful Web Resources


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