Considerations for the Development of Novel Chemotherapies and Antibody Drug Conjugates in Phase I Trials
The notion of using chemicals to treat diseases has been around since the turn of the twentieth century, with early discoveries coming serendipitously. By the 1950s, a Cancer Chemotherapy National Service Center (CCNSC) had begun to screen compounds for a
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Phase I Oncology Drug Development
Timothy A. Yap • Jordi Rodon • David S. Hong Editors
Phase I Oncology Drug Development
Editors Timothy A. Yap University of Texas MD Anderson Cancer Center Houston TX USA
Jordi Rodon University of Texas MD Anderson Cancer Center Houston TX USA
David S. Hong University of Texas MD Anderson Cancer Center Houston TX USA
ISBN 978-3-030-47681-6 ISBN 978-3-030-47682-3 (eBook) https://doi.org/10.1007/978-3-030-47682-3 © Springer Nature Switzerland AG 2020 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Foreword
The Times—They Are A-Changin’ —Bob Dylan Nobel Laureate for Literature 2016
It is certainly no longer “the bad old days” in the field of oncology phase I clinical trials. The days of treating patients with advanced refractory cancer when all prior treatments have failed them with just the next phase I agent coming off the drug development assembly line are thankfully over. Potential new therapeutic entities are becoming available for phase I clinical trials at a rapid clip. Whether we are referring a patient for a possible phase I trial or consenting a patient for a phase I study, we must make sure we are offering our patients the best possible chance they will actually benefit from that new agent. In the “bad old days,” only about 1 in every 15 or so new agents tried actually had evidence of helping someone in a phase I trial. Today, it is thankfully at least 1 in every 3 new agents (that will provide clinical benefit for a patient). In fact, with better science, better patient selection, etc., if no participant in a phase I trial derives benefit from the new agent, one quickly wonders whether there is any future at all for that drug. Ther
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