JSS Research Series in Statistics

Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents

Authors: Hirakawa, A., Sato, H., Daimon, T., Matsui, S.

  • Focuses on the two advanced areas of adaptive model-based dose-finding methods for phase I trials with multiple drugs/outcomes in oncology and other fields
  • Provides software implementations to facilitate planning of phase I trials using these methods in practice
  • Serves as an excellent handbook for design and analysis of early-phase dose-finding trials, for graduate students and postdoctoral fellows in biostatistics, statisticians, and clinical investigators
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eBook 41,64 €
price for Spain (gross)
  • ISBN 978-4-431-55573-5
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Softcover 51,99 €
price for Spain (gross)
  • ISBN 978-4-431-55572-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
About this book

This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of two agents. Development of dose-finding methods for two-agent combination trials requires reasonable models that can adequately capture joint toxicity probabilities for two agents, taking into consideration possible interactions of the two agents on toxicity probability such as synergistic or antagonistic effects. Another is clinical trials for evaluating both efficacy and toxicity outcomes in single- and two-agent combination trials. These methods are often applied to the phase I trials including MTAs because the toxicity and efficacy for a MTA does not monotonically increase with dose, but the efficacy often increases initially with the dose and then plateaus. Successful software implementations for several dose-finding methods are introduced in the book, and their operating characteristics in practice are discussed. Recent advance of the adaptive dose-finding methods in drug developments are also provided.

About the authors

- Akihiro Hirakawa, Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo
- Takashi Daimon, Division of Biostatistics, Hyogo College of Medicine
- Hiroyuki Satom, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
- Shigeyuki Matsui, Department of Biostatistics, Nagoya University Graduate School of Medicine

Table of contents (5 chapters)

  • Dose Finding in Phase I Cancer Trials

    Hirakawa, Akihiro (et al.)

    Pages 1-7

  • Dose Finding for a Combination of Two Agents

    Hirakawa, Akihiro (et al.)

    Pages 9-40

  • Dose Finding for Joint Assessment of Both Efficacy and Toxicity

    Hirakawa, Akihiro (et al.)

    Pages 41-58

  • Dose Finding for Molecularly Targeted Agents (MTAs)

    Hirakawa, Akihiro (et al.)

    Pages 59-80

  • Advanced Topics on Dose-Finding Designs

    Hirakawa, Akihiro (et al.)

    Pages 81-89

Buy this book

eBook 41,64 €
price for Spain (gross)
  • ISBN 978-4-431-55573-5
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Softcover 51,99 €
price for Spain (gross)
  • ISBN 978-4-431-55572-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
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Bibliographic Information

Bibliographic Information
Book Title
Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents
Authors
Series Title
JSS Research Series in Statistics
Copyright
2018
Publisher
Springer Japan
Copyright Holder
The Author(s)
Distribution Rights
distibution rights worldwide
eBook ISBN
978-4-431-55573-5
DOI
10.1007/978-4-431-55573-5
Softcover ISBN
978-4-431-55572-8
Series ISSN
2364-0057
Edition Number
1
Number of Pages
XIII, 89
Number of Illustrations and Tables
3 b/w illustrations
Topics