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

2018-01-30 Medical

Author : Akihiro Hirakawa
Release : 2018-01-30
Genre : Medical
Kind : eBook
Book Rating : 730/5 ( reviews)

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Book Synopsis Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents by : Akihiro Hirakawa

Download or read book Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents written by Akihiro Hirakawa. This book was released on 2018-01-30. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Novel Designs of Early Phase Trials for Cancer Therapeutics

2018-05-22 Medical

Author : Shivaani Kummar
Release : 2018-05-22
Genre : Medical
Kind : eBook
Book Rating : 705/5 ( reviews)

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Book Synopsis Novel Designs of Early Phase Trials for Cancer Therapeutics by : Shivaani Kummar

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar. This book was released on 2018-05-22. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Phase I Oncology Drug Development

2020-09-16 Medical

Author : Timothy A. Yap
Release : 2020-09-16
Genre : Medical
Kind : eBook
Book Rating : 820/5 ( reviews)

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Book Synopsis Phase I Oncology Drug Development by : Timothy A. Yap

Download or read book Phase I Oncology Drug Development written by Timothy A. Yap. This book was released on 2020-09-16. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

Phase I Cancer Clinical Trials

2014-06 Language Arts & Disciplines

Author : Elizabeth A. Eisenhauer
Release : 2014-06
Genre : Language Arts & Disciplines
Kind : eBook
Book Rating : 016/5 ( reviews)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer. This book was released on 2014-06. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it 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.

Phase I Cancer Clinical Trials

2015-03-20 Medical

Author : Elizabeth A. Eisenhauer
Release : 2015-03-20
Genre : Medical
Kind : eBook
Book Rating : 024/5 ( reviews)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer. This book was released on 2015-03-20. Available in PDF, EPUB and Kindle. Book excerpt: 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

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