Study Comparing Ripretinib and Sunitinib for Advanced GIST with Specific KIT Mutations After Imatinib Treatment
Sponsor: Deciphera Pharmaceuticals, LLC
ClinicalTrials ID:NCT05734105
This clinical trial is testing two drugs, ripretinib and sunitinib, to see which is more effective for patients with advanced gastrointestinal stromal tumors (GIST) that have specific genetic mutations and have progressed after initial treatment with imatinib.
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Program Overview
This study is designed to compare the effectiveness of two medications, ripretinib and sunitinib, in treating patients with advanced gastrointestinal stromal tumors (GIST) who have specific genetic mutations in the KIT gene. These patients have already been treated with imatinib but their cancer has progressed. If the cancer worsens while on sunitinib, patients have the option to switch to ripretinib.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of GIST with specific genetic mutations in the KIT gene (exons 11+17/18).
- The cancer must have progressed after treatment with imatinib.
- Be in relatively good health with an ECOG performance status of 2 or less.
- Women who can become pregnant must have a negative pregnancy test before starting the study.
- Must agree to use effective birth control methods.
- Have at least one tumor that can be measured by scans.
- Have good organ function and bone marrow health based on lab tests.
- Any side effects from previous treatments must be mild or back to normal before starting the study.
Exclusion Criteria
- Have a history of or current KIT exon 9, 13, or 14 mutations.
- Have active cancer spread to the brain.
- Have serious heart conditions or recent heart attack.
- Are taking certain medications that affect liver enzymes or have consumed grapefruit recently.
- Have had major surgery within the last 4 weeks.
- Have certain viral infections like HIV or hepatitis if taking specific medications.
- Have digestive issues that prevent taking oral medication or require IV feeding.
- Have any active bleeding, except minor bleeding like from hemorrhoids or gums.
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