A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

Exclusion Criteria

• •1. Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed.
• •3. Patient has known active central nervous system metastases.
• •4. New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
• •5. Left ventricular ejection fraction (LVEF) \< 50% at screening.
• •6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
• •7. Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
• •8. 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula \> 450 ms in males or \> 470 ms in females at screening or history of long QTc syndrome
• •9. Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
• •10. Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
• •11. Any other clinically significant comorbidities.
• •12. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
• •13. If female, the patient is pregnant or lactating.
• •14. Known allergy or hypersensitivity to any component of the study drug.
• •15. Gastrointestinal abnormalities including but not limited to:
• •* inability to take oral medication
• •* malabsorption syndromes
• •* requirement for intravenous (IV) alimentation
• •16. Any active bleeding excluding hemorrhoidal or gum bleeding.