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Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents

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 considera...

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Detalles Bibliográficos
Autores principales: Hirakawa, Akihiro, Sato, Hiroyuki, Daimon, Takashi, Matsui, Shigeyuki
Lenguaje:eng
Publicado: Springer 2018
Materias:
Acceso en línea:https://dx.doi.org/10.1007/978-4-431-55573-5
http://cds.cern.ch/record/2303156
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author Hirakawa, Akihiro
Sato, Hiroyuki
Daimon, Takashi
Matsui, Shigeyuki
author_facet Hirakawa, Akihiro
Sato, Hiroyuki
Daimon, Takashi
Matsui, Shigeyuki
author_sort Hirakawa, Akihiro
collection CERN
description 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.
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spelling cern-23031562021-04-21T18:55:23Zdoi:10.1007/978-4-431-55573-5http://cds.cern.ch/record/2303156engHirakawa, AkihiroSato, HiroyukiDaimon, TakashiMatsui, ShigeyukiModern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agentsMathematical Physics and MathematicsThis 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.Springeroai:cds.cern.ch:23031562018
spellingShingle Mathematical Physics and Mathematics
Hirakawa, Akihiro
Sato, Hiroyuki
Daimon, Takashi
Matsui, Shigeyuki
Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title_full Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title_fullStr Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title_full_unstemmed Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title_short Modern dose-finding designs for cancer phase I trials: drug combinations and molecularly targeted agents
title_sort modern dose-finding designs for cancer phase i trials: drug combinations and molecularly targeted agents
topic Mathematical Physics and Mathematics
url https://dx.doi.org/10.1007/978-4-431-55573-5
http://cds.cern.ch/record/2303156
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AT satohiroyuki moderndosefindingdesignsforcancerphaseitrialsdrugcombinationsandmolecularlytargetedagents
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AT matsuishigeyuki moderndosefindingdesignsforcancerphaseitrialsdrugcombinationsandmolecularlytargetedagents