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. Theauthors 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.

Paradigm shift in oncology drug development

Practicalities in setting up phase I trials
Optimizing the preclinical development of antitumor agents for entry into phase I trials
Considerations for the development of novel chemotherapies in phase I trials
Considerations for the development of novel targeted agents in phase I trials
Development of immunotherapeutic strategies in early phase clinical trials
Assessment of radiotherapeutic strategies in phase I trials
Development of combinatorial strategies in phase I trials
Novel trial designs for early phase clinical trials
Incorporating pharmacokinetic strategies for phase I trials
Development of pharmacodynamic biomarkers for phase I trials
Efficacy considerations for Phase I trials
Incorporating precision medicine into Phase I clinical trials
Molecular profiling of patients for clinical trials
Incorporating circulating biomarkers into clinical trials
Statistical considerations for early phase clinical trials
Lessons from hematology for solid tumor drug development.