A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Condition(s) studied
Investigational drug(s) / intervention(s)
Ripretinib: Oral KIT/PDGFRA kinase inhibitor
Sunitinib: Oral receptor tyrosine kinase (RTK) inhibitor
Study summary
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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population — From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
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. - Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population — From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
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.
Trial sites (121)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | |
| University of California San Diego Medical Center | La Jolla | California | |
| UCLA Hematology Oncology Center - Main Site | Los Angeles | California | |
| Stanford Medicine | Stanford | California | |
| University of Colorado Hospital - Anschutz Cancer Pavillion | Aurora | Colorado | |
| Rocky Mountain Cancer Centers | Denver | Colorado | |
| Smilow Cancer Hospital at Yale | New Haven | Connecticut | |
| Washington Cancer Institute at MedStar Washington Hospital Center | Washington D.C. | District of Columbia | |
| Mayo Clinic Florida | Jacksonville | Florida | |
| Sylvester Comprehensive Cancer Center | Miami | Florida | |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | |
| Orlando Health UF Health Cancer Center | Orlando | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Winship Cancer Institute | Atlanta | Georgia | |
| Georgia Cancer Specialists | Sandy Springs | Georgia | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| University of Chicago Medical Center | Chicago | Illinois | |
| IU Simon Cancer Center | Indianapolis | Indiana | |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | |
| Norton Cancer Institute, Audubon Hospital Campus | Louisville | Kentucky | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | |
| Rutgers Cancer Institute | New Brunswick | New Jersey | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| The Monter Cancer Center | Lake Success | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Montefiore Medical Center-Montefiore Medical Park | The Bronx | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute | Columbus | Ohio | |
| University of Toledo | Toledo | Ohio | |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| Oregon Health & Science University Center for Health and Healing | Portland | Oregon | |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | |
| University of Texas MD Anderson Cancer Center | Houston | Texas |
+ 81 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03673501 on ClinicalTrials.gov ↗ ← All trials in Italy