Basket, Umbrella and Adaptive Designs for Clinical Trials

A basket trial and an accelerated pathway to proof-of-concept

Precision for Medicine had been working with a sponsor on a trial with an adaptive approach to exploring multiple tumor types concurrently as an accelerated pathway to proof-of-concept. However, the study had to overcome multiple challenges including a limited patient population (2% to 8% of all solid tumors), a biomarker approach that was not “standard of care” for all of the targeted cancers, and a complex patient screening process. In addition, the site study staff had to be able to handle highly technical genomic data.

Precision was able to design and implement a clinical trial for this study that has resulted in a total of 20 tumor-specific cohorts pursued and 7 treatment approaches eliminated. The trial continues to add cohorts and tumor-specific explorations, both as single and combination treatment approaches, and what started as 100 patients across 6 sites is now being
conducted at ~50 sites globally with 250+ patients enrolled.

Find out how Precision overcame these study challenges in this case study.