Novel Designs of Early Phase Trials for Cancer Therapeutics

Provides discussions on early phase cancer trial designs, the process of drug development, and the integration of molecular profiling

Shivaani Kummar (Edited by), Chris Takimoto (Edited by)

9780128125120, Elsevier Science

Paperback, published 26 May 2018

234 pages
23.4 x 19 x 1.6 cm, 0.48 kg

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials.

Introduction: Changing landscape of phase I trials1. Phase I trial designs: Past, Present, and Future2. Statistical perspectives on cohort expansions in early phase trials3. Determining the optimal dose and schedule4. Conducting large phase I trials with multiple expansion cohorts5. Role and application of molecular profiling in early phase trials6. Novel trial designs for immunotherapies7. Designing trials for cell based therapies8. Evaluating novel drug combinations in early phase trials9. Integrating biomarkers in early phase trials: developing the evidence base for ‘actionable’ biomarkers10. Novel imaging endpoints in early phase trials11. Developing a novel agent: the regulatory process perspective12. Conducting proof of concept phase I trials-Regulatory Implications13. Efficacy endpoints in early phase trials14. Incorporation of Patient Reported Outcomes in early phase trials

Subject Areas: Biomedical engineering [MQW], Oncology [MJCL]