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Clinical Trials in the UK / NCT05734105
Active, not recruiting Phase 3

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

NCT05734105 · tracked via the Priya Life Science UK tracker
Sponsor
Deciphera Pharmaceuticals, LLC
Phase
Phase 3
Started
2023-12-13
Last updated
2025-12-17

Condition(s) studied

GIST

Investigational drug(s) / intervention(s)

RipretinibSunitinib

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male or female ≥18 years of age. 2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample. 3. Participants must have advanced GIST and radiologic progression on imatinib treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening. 5. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug. 6. Participants of reproductive potential must agree to follow contraception requirements. 7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug. 8. Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening. Exclusion Criteria: 1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample. 2. Has known active central nervous system metastases. 3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6 months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure. 4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to the first dose of study drug, and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug. 5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. 6. Known human immunodeficiency virus or hepatitis C infection only if the participant is taking medications that are excluded per protocol, acute or chronic hepatitis B, or acute or chronic hepatitis C infection. 7. Gastrointestinal abnormalities including, but not limited to: 1. inability to take oral medication 2. malabsorption syndromes 3. requirement for intravenous alimentation 8. Any active bleeding excluding hemorrhoidal or gum bleeding.

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
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 the UK

Official registry record

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 the UK