A Case Study for Determining a Target Expression Cut-Point
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*Alan Hughes Hartford, AbbVie 

Keywords: personalized medicine, expression level, oncology

Investigating biomarker subgroups in early clinical development may determine who will benefit most from a treatment and provide a greater probability of success for Phase 3. A case study of a targeted therapy in a phase 2 metastatic pancreatic cancer trial will be presented to examine several key elements in the personalized medicine paradigm including the perspective of the investigators enrolling patients, complications of determining a predictive target expression cut point, interpretation of study results, and complications of designing future studies.