Last updated 56 days ago
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
54 patients around the world
Available in Brazil, Chile
Deciphera Pharmaceuticals LLC
8Research sites
54Patients around the world
This study is for people with
Gastrointestinal stromal tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female ≥18 years of age.Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.Participants must have advanced GIST and radiologic progression on imatinib treatment.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.Participants of reproductive potential must agree to follow contraception requirements.Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.Resolution of all toxicities from prior therapy to Grade ≤1 (or participant baseline) within 1 week prior to the first dose of study drug.
- History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.Has known active central nervous system metastases.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.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.Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.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.Gastrointestinal abnormalities including, but not limited to:Inability to take oral medication.Malabsorption syndromes.Requirement for intravenous alimentation.Any active bleeding excluding hemorrhoidal or gum bleeding.
Sites
Hospital Nove de Julho
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
AC Camargo Cancer Center
Recruiting
CEPEN - CENTRO DE PESQUISA E ENSINO DE SANTA CATARINA
Recruiting
Clínica San Carlos de Apoquindo - Red de Salud UC Christus
Recruiting
Centro de Oncología de Precisión
Recruiting
StudyINSIGHT
SponsorDeciphera Pharmaceuticals LLC
Conditions
Gastrointestinal stromal tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05734105
