Claims for Patent: 11,426,390

Summary for Patent: 11,426,390

Title:	Methods of treating gastrointestinal stromal tumors
Abstract:	The present disclosure relates to methods of treating gastrointestinal stromal tumors to a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof.
Inventor(s):	Soto; Rodrigo Ruiz (Waltham, MA), Rosen; Oliver (Waltham, MA), Pitman; Jama (Waltham, MA)
Assignee:	Deciphera Pharmaceuticals, LLC (Waltham, MA)
Application Number:	17/583,977
Patent Claims:	1. A method of treating a patient suffering from an advanced gastrointestinal stromal tumor, and where the patient is being treated concurrently with a CYP3A4 inhibitor, comprising orally administering to the patient a 150 mg daily dose of ripretinib, wherein the administration of the CYP3A4 inhibitor and the ripretinib to the patient increases ripretinib area under the plasma concentration curve (AUC.sub.0-inf) by 80% or more in the patient as compared to administration of ripretinib without concurrent treatment of the CYP3A4 inhibitor, and therefore the patient is at higher risk of an adverse event; and monitoring the patient for the adverse event due to the ripretinib and CY3A4 inhibitor administration. 2. The method of claim 1, wherein if the patient suffers from an adverse event upon administration of the ripretinib and the CY3A4 inhibitor, the method further comprises administering to the patient a reduced dose of 100 mg daily of the ripretinib. 3. The method of claim 1, wherein if the patient suffers from a Grade 3 adverse event selected from the group consisting of arthralgia, myalgia and palmer-plantar erythrodysesthia syndrome after administration of the ripretinib and the CYP3A4 inhibitor, the method further comprises: a) withholding administration of the ripretinib for at least 7 days or until the patient has less than or equal to grade 1 of the adverse event, then b) administering to the patient 100 mg daily of the ripretinib for at least 28 days. 4. The method of claim 1, wherein if the patient suffers from a Grade 3 adverse event after the administration of the ripretinib and the CYP3A4 inhibitor, the method further comprises: a) withholding administration of the ripretinib for at least 7 days or until the patient has less than or equal to grade 1 of the adverse event, then b) administering to the patient 100 mg daily of the ripretinib for at least 28 days. 5. The method of claim 1, wherein the adverse event is one or more of: nausea, vomiting, anemia or abdominal pain. 6. The method of claim 1, wherein the CYP3A4 inhibitor is selected from the group consisting of itraconazole, ketoconazole, clarithromycin, and indinavir.