The Development of a Drug: A Pharmaceutical Drug Development Perspective
Michael Lahn
Pages 1-15
Paradigms in Cancer Drug Development: A Universe with Many Galaxies
Cinta Hierro, Jordi Rodon
Pages 17-44
Preclinical Studies to Enable First in Human Clinical Trials
Rajesh Chopra, Florence I. Raynaud
Pages 45-69
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
David S. Hong, Kathrina L. Marcelo-Lewis, Patricia LoRusso
Pages 71-83
Novel Trial Designs for Early Phase Clinical Trials
Chia-Chi Lin
Pages 85-93
Examining Performance of Phase I Designs: 3+3 Versus Bayesian Optimal Interval (BOIN)
Kenneth R. Hess, Bryan M. Fellman
Pages 95-107
Considerations for the Attribution and Management of Toxicities in Phase I Clinical Trials
Pedro C. Barata, David S. Hong
Pages 109-118
Strategies for Incorporating Pharmacokinetic Studies into Oncology Phase I Trials
Lingzhi Wang, Wan Qin Chong, Pei Shi Ong, Boon Cher Goh
Pages 119-138
Development of Pharmacodynamic Biomarkers for Phase I Trials
María Vieito, Itziar Gardeazabal, Ignacio Matos, Elena Garralda
Pages 139-158
Efficacy Considerations in Phase I Trials
Kanan Alshammari, Kirsty Taylor, Lillian L. Siu
Pages 159-183
Considerations for the Development of Novel Chemotherapies and Antibody Drug Conjugates in Phase I Trials
Vivek Subbiah, Roman Groisberg
Pages 185-198
Development of Molecularly Targeted Agents in Early Phase Clinical Trials
Pedro C. Barata, Timothy A. Yap
Pages 199-220
Incorporating Precision Medicine into Phase I Clinical Trials
Funda Meric-Bernstam
Pages 221-231
Incorporating Circulating Biomarkers into Clinical Trials
Filip Janku
Pages 233-247
Development of Immunotherapeutic Strategies for Early Phase Clinical Trials
Patricia Martin-Romano, Roman Chabanon, Adrien Procureur, Sandrine Aspeslagh, Sophie Postel-Vinay
Pages 249-282
Radiotherapy Considerations and Strategic Approaches in Phase I Trials
Lauren E. Colbert, Ying Yuan, Jaap D. Zindler, Clifton D. Fuller, Charles R. Thomas
Pages 283-296
The Paradigm of Early Phase Studies in Hematological Malignancies
Vishwanath Sathyanarayanan, Swaminathan P. Iyer
Pages 297-311
Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development
Analia Azaro, Mehmet Esat Demirhan, Joann Lim, Jordi Rodon
Pages 313-342

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.