This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
453
Oral KIT/PDGFRA kinase inhibitor
Oral receptor tyrosine kinase (RTK) inhibitor
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: From confirmed CR or PR to disease progression (up to 1.74 years)
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
University of California San Diego Medical Center
La Jolla, California, United States
UCLA Hematology Oncology Center - Main Site
Los Angeles, California, United States
Stanford Medicine
Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Smilow Cancer Hospital at Yale
New Haven, Connecticut, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
...and 111 more locations
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: From confirmed CR or PR to disease progression (up to 1.74 years)
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
OS was defined as the time from the date of randomization until death due to any cause.
Time frame: From date of randomization until death due to any cause (up to 3.33 years)
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
OS was defined as the time from the date of randomization until death due to any cause.
Time frame: From date of randomization until death due to any cause (up to 3.33 years)