Clinical Trials | An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT)

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with Gastrointestinal Stromal Tumor (GIST). The purpose of this study is to learn how well ripretinib, the study drug, works against GIST as compared to sunitinib in patients with specific gene mutations who have progressed while receiving imatinib. This is a randomized, open-label research study. This means that you will be assigned by computer to receive either ripretinib or sunitinib. You will have 2 out of 3 chance of receiving ripretinib and a 1 out of 3 chance of receiving sunitinib. You will know which study drug you are receiving. If at any time during the study your cancer has worsened (progression based on your tumor images) and you are receiving sunitinib, you may choose to switch to ripretinib. Ripretinib will be taken in the form of a tablet and sunitinib will be taken in the form of a capsule. If you are randomized to take ripretinib, you will take ripretinib 150 mg once daily during the study in 6 week cycles. If you are randomized to take sunitinib, you will take sunitinib 50 mg once daily on a schedule of 4 weeks on treatment followed by 2 weeks off. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: • https://clinicaltrials.gov/study/NCT05734105 • https://www.exploreinsightgist.com/ [email protected]