Phase I Oncology Drug Development

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

23 December, 2020

Phase I Oncology Drug Development

Timothy A. Yap, Jordi Rodon, and David S. Hong

Phase I Oncology Drug Development is a book published by Springer in 2020 (first edition) and written by Timothy A. Yap, Jordi Rodon, and David S. Hong.

Book Purpose & Audience

Phase I Oncology Drug Development offers an overview of how cancer drug development has evolved in the past years, being a practical guide for phase I clinical studies.

This book seeks to help doctors better understand phase I clinical trials, but it will also be helpful for translational investigators and professionals dedicated to drug development activities. 

In addition, this volume will be useful for study coordinators and nurses providing support in clinical trials.

Book Contents

This 560-page book contains 18 chapters covering the following topics:

  1. The development of a drug: a pharmaceutical drug development perspective
  2. Paradigms in cancer drug development: a universe with many galaxies
  3. Preclinical studies to enable first in human clinical trials
  4. Practicalities of setting up a phase I clinical trial unit within an academic center
  5. Novel trial designs for early phase clinical trials
  6. Examining performance of phase I designs: 3+3 versus Bayesian Optimal Interval (BOIN)
  7. Considerations for the attribution and management of toxicities in phase I clinical trials
  8. Strategies for incorporating pharmacokinetic studies into oncology phase I trials
  9. Development of pharmacodynamic biomarkers for phase I trials
  10. Efficacy considerations in phase I trials
  11. Considerations for the development of novel chemotherapies and antibody drug conjugates in phase I trials
  12. Development of molecularly targeted agents in early phase clinical trials
  13. Incorporating precision medicine into phase I clinical trials
  14. Incorporating circulating biomarkers into clinical trials
  15. Development of immunotherapeutic strategies for early phase clinical trials
  16. Radiotherapy considerations and strategic approaches in phase I trials
  17. The paradigm of early phase studies in hematological malignancies
  18. Pharmacokinetic considerations for organ dysfunction clinical trials in early drug development

About the Authors

  • Timothy A. Yap: Medical Oncologist and Physician-Scientist, University of Texas MD Anderson Cancer Center. Associate Professor in the Department for Investigational Cancer Therapeutics.
  • Jordi Rodon: MD Anderson’s Investigational Cancer Therapeutics. Former Director and Clinical Head of the Research Unit for Molecular Therapy of Cancer at the Vall d’Hebron University Hospital in Barcelona, Spain.
  • David S. Hong: Deputy Chair at the department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center.

What Do You Think About This Book?

What is your opinion about Phase I Oncology Drug Development? What did you like most? What are the strengths and weaknesses of this volume? 

Please share your comments below and give a more complete perspective to the drug development community!

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com