Brief Summary
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.
Intervention / Treatment
- Drug: Ripretinib
- Drug: Sunitinib
Inclusion Criteria:
- Male or female ≥18 years of age.
- Histologic diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
- Participants must have advancedat a late stage, far along GIST and radiologic progression on imatinib treatment.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) of ≤2 at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dosethe amount of medication taken of study drug.
- Participants of reproductive potential must agree to follow contraception requirements.
- Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrowsoft, spongy tissue found in bones that makes blood cells reserve based on laboratory assessments performed at screening.
- Resolution of all toxicities from prior therapy to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤1 (or participant baseline) within 1 week prior to the first dose of study drug.