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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
50 mg tablets
12.5 mg tablets
UC San Diego Moores Cancer Center
La Jolla, California, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Progression-free Survival (PFS)
The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
Time frame: Up to end of treatment; up to approximately 48 months
Objective Response Rate (ORR)
Compare ORR by IRR of ripretinib vs sunitinib using mRECIST
Time frame: Up to end of treatment; up to approximately 48 months
Overall Survival (OS)
Compare OS of ripretinib vs sunitinib
Time frame: Up to approximately 48 months
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 60 more locations