Case Study – Oncology: ODC Turned Brazil into the World’s #1 Country for a Biomarker-Selected Global Precision Oncology Trial (GIST)
Challenge The INSIGHT Phase III trial — evaluating ripretinib vs. sunitinib in advanced GIST — required patients with a highly specific KIT resistance genotype: exon 11 plus secondary exon 17/18 mutations, explicitly excluding exon 9, 13, or 14. With 55 patients enrolled globally across 70 sites in 15 countries, finding eligible patients demanded molecular precision, ctDNA pathway coordination, and active referral follow-up at every step of the funnel.
Strategy
- Mapping Specialized Oncology Centers: Prioritized sarcoma and GI oncology centers with high-volume advanced GIST patient pools and access to molecular profiling — concentrating prescreening effort where eligible patients could actually be found.
- Building a Prescreening Engine: ODC activated a systematic country-level tracker, turning passive waiting into active hunting. Site teams reviewed patient databases, flagged post-imatinib progressors, and maintained a structured candidate pipeline.
- Coordinating the Molecular Pathway: Provided end-to-end support for ctDNA logistics — sample collection, lab coordination, result interpretation — ensuring molecular data arrived within clinically relevant windows and did not delay screening decisions.
Results & Why This Matters
- ~21% of global pre-screenings were generated by Brazil, increasing the main trial recruitment driver – Brazil as the top enrolling country alongside the USA & France.
- 113 patients were prescreened in Brazil, 10 patients were confirmed eligible, 9 were enrolled, matching France and the United States as the Top enrolling countries.
- Brazil reduced global dependence on North America and Europe, proving LATAM can function as a peer-level strategic geography in molecularly complex, small-sample-size trials.
INSIGHT Phase III Trial Details Ripretinib vs Sunitinib in Advanced GIST KIT Exon 11 + Secondary Exon 17/18 Mutations George S, et al. Future Oncology 2024 – Heinrich M, et al. Nature Medicine 2024 NCT05734105 – Deciphera Pharmaceuticals
- 55 patients enrolled globally
- 15 countries represented
- 9 patients Enrolled (BR)
- #1 Tied for Top enroller with USA & France
