Trial Title:
A Study of Ripretinib Vs Sunitinib in Patients with Advanced GIST with Specific KIT Exon Mutations Who Were Previously Treated with Imatinib
NCT ID:
NCT05734105
Condition:
GIST
Conditions: Official terms:
Sunitinib
Conditions: Keywords:
advanced gastrointestinal tumors
gastrointestinal stromal tumors
imatinib
ripretinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ripretinib
Description:
50 mg tablets
Arm group label:
Ripretinib
Other name:
QINLOCK, DCC-2618
Intervention type:
Drug
Intervention name:
Sunitinib
Description:
12.5 mg tablets
Arm group label:
Sunitinib
Other name:
Sutent
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.
Criteria for eligibility:
Criteria:
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.
9. Resolution of all toxicities from prior therapy to Grade ≤1 (or participant
baseline) within 1 week prior to the first dose of study drug.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Facility:
Name:
Boston Medical Center
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
M Health Fairview University of Minnesota Medical Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center
Address:
City:
New York
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
CEPEN - Centro de Pesquisa e Ensino em Saude de Santa Catarina
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Cancer de Barretos - Fundacao Pio XII
Address:
City:
Barretos
Zip:
14748-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sirio-Libanes
Address:
City:
São Paulo
Zip:
01308
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital 9 de Julho
Address:
City:
São Paulo
Zip:
01409-002
Country:
Brazil
Status:
Recruiting
Facility:
Name:
INCA - Instituto Nacional de Cancer
Address:
City:
Rio De Janeiro
Zip:
20231
Country:
Brazil
Status:
Recruiting
Facility:
Name:
AC Camargo Câncer Center
Address:
City:
São Paulo
Zip:
01509-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Facility:
Name:
University Health Network, Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Clínica San Carlos De Apoquindo Red Salud UC Christus
Address:
City:
Las Condes
Zip:
7620002
Country:
Chile
Status:
Recruiting
Facility:
Name:
Centro de Oncología de Precisión
Address:
City:
Santiago
Zip:
7550000
Country:
Chile
Status:
Recruiting
Facility:
Name:
CHU Dijon
Address:
City:
Dijon Cedex
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Helios Klinikum Berlin-Buch
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Essen (Universitätsklinikum Essen)
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione "G Pascale"
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Oncologico Veneto-IOV IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
U.O.C. Oncologia Medica
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Università Campus Bio-Medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Zip:
9713
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
LUMC
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii Im . Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Address:
City:
Warsaw
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Address:
City:
Vigo
Zip:
36312
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto Valenciano de Oncologia - IVO
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
The Royal Marsden Hospital NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St. James University Hospital
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Start date:
December 13, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Deciphera Pharmaceuticals, LLC
Agency class:
Industry
Source:
Deciphera Pharmaceuticals, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05734105
