Phase I clinical trials attrition related to central molecular prescreening.

2600 Background: The increasing trend to incorporate molecular assays as part of selection assessment in Ph1 trials is based on the potential to observe early antitumor activity. Nonetheless, its impact has been almost negligible to date and might affect time to achieve a recommended dose. We assessed the impact on recruitment of pursuing central mandatory molecular assessment of tumor samples on a state-of-the-art Ph1 unit. Methods: Two first-in-human Ph1 studies, requiring central laboratory biomarker assessment as inclusion criterion (DS6 IHC and FGFR mut/ampl, respectively), and a consecutive series of pts in our program for central tumor mutation screening (OncoCarta Panel v1.0) to participate in molecularly-driven Ph1 studies, were reviewed. Results: 13 (4.8%) out of 267 pre-screened pts were able to receive treatment within a targeted Ph1 trial. Conclusions: A vast majority of pts trying to participate in molecularly-driven trial central biomarker screening are not included due to negative results....