Abstract

Phase I trials historically involve heavily pretreated patients (pts) with no more effective therapeutic options available and generally with poor expected outcomes (objective response rate (ORR): 9% and mOS: 9.9 mo, Arkenau et. al, BJH 2008). Phase I trials evolved over the past years and are now widely considered. However, there is scare data regarding phase I cancer centers activity and outcomes of pts enrolled into modern phase I trials. Here, we sought to provide an overview of pts inclusions and outcomes into early phase trials at Gustave Roussy (GR) over the last 5 years.

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