(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
NCT ID: NCT05208047
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
442 participants
INTERVENTIONAL
2022-04-14
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1a
CGT9486 plus sunitinib 37.5 mg QD
CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Part 2 - Experimental Group
CGT9486 plus sunitinib 37.5 mg QD
CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Part 2 - Control Group
sunitinib 37.5 mg QD
Sunitinib
Participants will receive sunitinib orally until study stopping rules are met.
Part 1b - DDI Cohort 1
CGT9486 plus sunitinib 37.5 mg QD
CGT9486
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Part 1b - DDI Cohort 2
sunitinib 37.5 mg QD plus CGT9486
Sunitinib
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
DDI Substudy (Midazolam)
Midazolam, CGT9486, sunitinib
Midazolam
Participants will receive a single-dose of midazolam on Day 1 and Day 16
CGT9486 plus sunitinib
Patients will receive CGT9486 orally starting on Day 2 and sunitinib starting on Day 16 until study stopping rules are met.
Interventions
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CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
CGT9486
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Sunitinib
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
Sunitinib
Participants will receive sunitinib orally until study stopping rules are met.
Midazolam
Participants will receive a single-dose of midazolam on Day 1 and Day 16
CGT9486 plus sunitinib
Patients will receive CGT9486 orally starting on Day 2 and sunitinib starting on Day 16 until study stopping rules are met.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented disease progression on or intolerance to imatinib
3. Subjects must have received the following treatment:
DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST Part 1b: Treatment with ≥2 prior TKI for GISTs Part 2: Prior treatment with imatinib only
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
Exclusion Criteria
2. Clinically significant cardiac disease
3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
5. Any active bleeding excluding hemorrhoidal or gum bleeding
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8. Received strong CYP3A4 inhibitors or inducers
9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)
18 Years
ALL
No
Sponsors
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Cogent Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of Arizona- Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
University of California, San Diego (UCSD)
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver
Denver, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Tennessee
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, United States
Instituto Alexander Fleming
Buenos Aires, , Argentina
Instituto Oncologico de Cordoba (IONC)
Córdoba, , Argentina
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Bankstown-Lidcombe Hospital
Bankstown, , Australia
Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
Campinas, , Brazil
lnstituto Nacional de Cancer - INCA
Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo, , Brazil
Alberta Health Services Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Tom Baker Cancer Center
Calgary, , Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal, , Canada
Instituto Oncologico FALP
Santiago, , Chile
Centro de Oncologia de Precision, Universidad Mayor
Santiago, , Chile
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc - Oncology clinic
Olomouc, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
AP-HM - Hôpital de la Timone
Marseille, , France
Centre Eugene Marquis
Rennes, , France
ICO St-Herblain
Saint-Herblain, , France
CHU de Toulouse - Hospital Rangueil
Toulouse, , France
Gustave Roussy
Villejuif, , France
Helios Klinikum Bad Saarow
Bad Saarow, , Germany
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover- Urology Oncology
Hanover, , Germany
Universitaetsmedizin Mannheim
Mannheim, , Germany
Humanity & Health Clinical Trial Centre
Central, , Hong Kong
Hong Kong United Oncology Centre
Jordon, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
Debrecen, , Hungary
Centro Riferimento Oncologico - Aviano
Aviano, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
ASST degli Spedali Civili di Brescia
Brescia, , Italy
IRCCS La Fondazione e l'Istituto di Candiolo
Candiolo, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona, , Italy
Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes, , Mexico
I Can Oncology Center SA De CV
Monterrey, , Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, , Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam, , Netherlands
UMC Groningen
Groningen, , Netherlands
Stichting Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haukeland University Hospital - Bergen
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Szpital Specjalistyczny w Brzozowie
Brzozów, , Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
Gliwice, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, , Poland
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Hosptial
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Skane University Hospital Lund
Lund, , Sweden
Karolinska University Hospital
Solna, , Sweden
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
National Taiwan University Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital (VGHTP)
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)
Taoyuan District, , Taiwan
Cambridge Addenbrooke's Hospital
Cambridge, , United Kingdom
Beatson, West of Scotland Cancer Centre
Glasgow, , United Kingdom
University College London Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Royal Marsden Hospital - Surrey
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Other Identifiers
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CGT9486-21-301
Identifier Type: -
Identifier Source: org_study_id
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