A Phase 3 Study of Ripretinib Versus Sunitinib in People With Advanced GIST Tumors With Certain Genetic Changes

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Full Title

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) (WCG IRB)

Purpose

Researchers are comparing ripretinib with sunitinib in people with gastrointestinal stromal tumors (GIST) that keep growing even with imatinib treatment. The people in this study have GIST with certain mutations (changes or variants). 

In you join this study, you will be randomly assigned to take either ripretinib or sunitinib. Both drugs are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have GIST that keeps growing even after imatinib treatment.
  • Have genetic changes called KIT exon 11 and co-occurring KIT exon 17 or 18 mutations in the tumor.
  • Have recovered from the serious side effects of prior therapies.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Ping Chi’s office at 646-888-4166.

Protocol

23-261

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05734105