Ph1 oncology pancreas and GI tumor study
Ph1 oncology pancreas and GI tumor study, only site-determined responders would be reviewed centrally to confirm; at 50% subjects enrolled, no responders seen but 3 prolonged stable disease subjects identified.
RadMD asked to centrally confirm 3 stable pancreas tumor subjects, and instead identified the site had misinterpreted benign pancreatitis as tumor in 2/3 subjects.
Sponsor requested all subjects reviewed, RadMD identified 3 responders that sites misinterpreted as benign. Implemented independent confirmation of disease progression process whenever site identified progression for remainder of subjects.
Study would have been closed based on site reads; central review identified responders, sponsor initiated Phase 2 study based on central review.