A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Summary

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

Timeline

Start

2023-12-13

Primary completion

2027-12

Completion

2028-12

Publications

• George S, Blay JY, Chi P, Jones RL, Serrano C, Somaiah N, Gelderblom H, Zalcberg JR, Reichmann W, Sprott K, Cox P, Sherman ML, Ruiz-Soto R, Heinrich MC, Bauer S. The INSIGHT study: a randomized, Phase III study of ripretinib versus sunitinib for advanced gastrointestinal stromal tumor with KIT exon 11 + 17/18 mutations. Future Oncol. 2024;20(27):1973-1982. doi: 10.1080/14796694.2024.2376521. Epub 2024 Sep 4.

Drugs

Indications