A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Condition(s) studied
Investigational drug(s) / intervention(s)
Ripretinib: 50 mg tablets
Sunitinib: 12.5 mg tablets
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to end of treatment; up to approximately 48 months
The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | |
| Yale University | New Haven | Connecticut | |
| Mayo Clinic Florida | Jacksonville | Florida | |
| Sylvester Comprehensive Cancer Center | Miami | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Boston Medical Center | Boston | Massachusetts | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center | New York | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| Oregon Health & Science University | Portland | Oregon | |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| University of Virginia | Charlottesville | Virginia | |
| Fred Hutchinson Cancer Center | Seattle | Washington | |
| Prince of Wales Hospital | Randwick | New South Wales | |
| Alfred Health | Melbourne | Victoria | |
| INCA - Instituto Nacional de Cancer | Rio de Janeiro | Rio de Janeiro | |
| CEPEN - Centro de Pesquisa e Ensino em Saude de Santa Catarina | Florianópolis | Santa Catarina | |
| Hospital de Cancer de Barretos - Fundacao Pio XII | Barretos | São Paulo | |
| Hospital Sirio-Libanes | São Paulo | São Paulo | |
| Hospital 9 de Julho | São Paulo | São Paulo | |
| AC Camargo Câncer Center | São Paulo | São Paulo | |
| Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Alberta | |
| Juravinski Cancer Centre | Hamilton | Ontario | |
| University Health Network, Princess Margaret Cancer Centre | Toronto | Ontario | |
| McGill University Health Centre | Montreal | Quebec | |
| Clínica San Carlos De Apoquindo Red Salud UC Christus | Las Condes | RM | |
| Centro de Oncología de Precisión | Santiago | RM | |
| CHU Dijon | Dijon | Bourgogone | |
| Centre Eugène Marquis | Rennes | Ille et Vilaine | |
| Institut Bergonié | Bordeaux | France | |
| Centre Léon Bérard | Lyon | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Helios Klinikum Berlin-Buch | Berlin | Germany |
+ 30 more sites — see the full list on the official registry below.
More Deciphera Pharmaceuticals, LLC trials in Italy
Other trials for the same condition
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 NCT05734105 on ClinicalTrials.gov ↗ ← All trials in Italy