Phase I cancer clinical trials : a practical guide / edited by Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse.

Format:

Book

Contributor:

Eisenhauer, Elizabeth A., editor.

Twelves, Chris, editor.

Buyse, Marc E., editor.

Eisenhauer, Elizabeth A.

ebrary, Inc.

Class of 1891 Department of Arts Fund.

Language:

English

Subjects (All):

Neoplasms--therapy.

Clinical Trials, Phase I as Topic--methods.

Cancer--Treatment.

Cancer.

Clinical trials.

Medical Subjects:

Neoplasms--therapy.

Clinical Trials, Phase I as Topic--methods.

Physical Description:

1 online resource (xi, 356 pages)

polychrome

Edition:

Second edition.

Other Title:

Phase one cancer clinical trials

Place of Publication:

Oxford ; New York : Oxford University Press, [2015]

System Details:

text file

Summary:

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 of 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 specialists and trainees 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. Book jacket.

Contents:

Preclinical data and requirements / Sophie Postel-Vinay, Jean-Charles Soria, Elizabeth A. Eisenhauer

Phase 0 clinical trials / Shivaani Kummar and James H. Doroshow

Basics of phase I design : first-in-man studies / Donna M. Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, and Lillian l. Siu

Ethical issues in first-in-human phase I cancer trials / Elizabeth A. Eisenhauer

Phase I trials in special populations and circumstances / Rajiv Kumar, Christopher Twelves, and Udai Banerji

Phase I trials of immunotherapeutics / Christy Ralph, Emma King, Christopher Twelves, and Christian Ottensmeier

Statistical designs for first-in-human phase I trials / Xavier Paoletti and Marc Buyse

Writing the protocol : Penelope A. Bradbury and Elizabeth A. Eisenhauer

Practical aspects of pharmacokinetics and pharmacodynamics / Christopher Twelves, Maria Jove, and Paul Loadman

Process, pitfalls, and logistics of phase I trials / Elizabeth A. Eisenhauer, Hayley Isenhauer, and Lesley K. Seymour.

Notes:

Preceded by Phase I cancer clinical trials : a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006.

Includes bibliographical references and index.

Electronic reproduction. Palo Alto, Calif. Available via World Wide Web.

Description based on online resource; title from digital title page (viewed on March 24, 2015).

Local Notes:

Acquired for the Penn Libraries with assistance from the Class of 1891 Department of Arts Fund.

Related Work:

Eisenhauer, Elizabeth A. Phase I cancer clinical trials.

Other Format:

Print version: Phase I cancer clinical trials.

ISBN:

9780199359028

0199359024

Publisher Number:

99962611207

Access Restriction:

Restricted for use by site license.