(Peak) a Phase 3 Randomized Trial of CGT9486+Sunitinib Vs. Sunitinib in Subjects with Gastrointestinal Stromal Tumors

Last updated: December 5, 2024
Sponsor: Cogent Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Metastatic Cancer

Abdominal Cancer

Gastrointestinal Diseases And Disorders

Treatment

Midazolam

CGT9486

CGT9486 plus sunitinib

Clinical Study ID

NCT05208047
CGT9486-21-301
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 442 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Additionally, a drug-drug interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.Molecular pathology report must be available for Part 2; if molecular pathologyreport is unavailable or inadequate, an archival or fresh tumor tissue sample willbe required to evaluate mutational status prior to randomization.

  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

  1. ECOG - 0 to 2

  2. Have clinically acceptable local laboratory screening results (clinical chemistryand hematology) within certain limits

Exclusion

Key Exclusion Criteria:

  1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency

  2. Clinically significant cardiac disease

  3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of studydrug

  4. Gastrointestinal abnormalities including, but not limited to, significant nausea andvomiting, malabsorption, external biliary shunt, or significant bowel resection thatwould 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 orhepatitis 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)

Study Design

Total Participants: 442
Treatment Group(s): 4
Primary Treatment: Midazolam
Phase: 3
Study Start date:
April 14, 2022
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

    2.92 miles

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

    131.8 miles

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

    188.22 miles

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

    208.4 miles

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

    224.9 miles

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Site Not Available

    290.64 miles

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

    328.64 miles

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

    356.48 miles

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

    391.98 miles

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

    394.93 miles

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

    422.06 miles

  • University of Tennessee

    Knoxville, Tennessee 37920
    United States

    Site Not Available

    427.36 miles

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

    567.79 miles

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

    594.03 miles

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

    646.63 miles

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Site Not Available

    659.03 miles

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

    708.93 miles

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Site Not Available

    715.51 miles

  • Washington University

    St. Louis, Missouri 63130
    United States

    Active - Recruiting

    715.51 miles

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

    729.4 miles

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Site Not Available

    758.69 miles

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

    787.45 miles

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

    810.99 miles

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

    876.07 miles

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

    923.88 miles

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

    942.75 miles

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

    1,016.68 miles

  • University of Colorado Denver

    Denver, Colorado 80204
    United States

    Active - Recruiting

    1,491.19 miles

  • I Can Oncology Center SA De CV

    Monterrey, 64710
    Mexico

    Site Not Available

    1,629.9 miles

  • Centro de Investigacion Medica Aquascalientes (CIMA)

    Aguascalientes, 20116
    Mexico

    Site Not Available

    1,898.84 miles

  • Oaxaca Site Management Organization S.C.

    Oaxaca, 68000
    Mexico

    Site Not Available

    1,919.09 miles

  • University of Arizona- Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

    1,948.59 miles

  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

    Site Not Available

    1,959.74 miles

  • Tom Baker Cancer Center

    Calgary, T2N 4N2
    Canada

    Site Not Available

    1,968.73 miles

  • Alberta Health Services Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

    1,984.26 miles

  • University of California, San Diego (UCSD)

    San Diego, California 92093
    United States

    Site Not Available

    2,269.74 miles

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

    2,276.95 miles

  • University of California, Los Angeles (UCLA)

    Los Angeles, California 90404
    United States

    Site Not Available

    2,307.31 miles

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

    2,322.84 miles

  • Oregon Health & Science University (OHSU)

    Portland, Oregon 97239
    United States

    Site Not Available

    2,348.65 miles

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

    2,348.65 miles

  • University of California, San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

    2,433.88 miles

  • Beatson, West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

    3,422.58 miles

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

    3,539.95 miles

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SJ
    United Kingdom

    Site Not Available

    3,572.49 miles

  • Cambridge Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

    3,659.89 miles

  • University College London Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

    3,665.01 miles

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

    3,665.01 miles

  • Royal Marsden Hospital - Surrey

    London, SW3 6JJ
    United Kingdom

    Site Not Available

    3,665.01 miles

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Site Not Available

    3,676.61 miles

  • Haukeland University Hospital - Bergen

    Bergen, 5021
    Norway

    Site Not Available

    3,685.8 miles

  • ICO St-Herblain

    Saint-Herblain, 44800
    France

    Site Not Available

    3,699.47 miles

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

    3,762.77 miles

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

    3,783.11 miles

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

    3,783.11 miles

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

    3,783.11 miles

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

    3,783.11 miles

  • Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

    3,807.59 miles

  • Centre Oscar Lambret

    Lille, 59000
    France

    Site Not Available

    3,815.7 miles

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

    3,833.1 miles

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

    3,841.85 miles

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

    3,846.09 miles

  • Oslo University Hospital

    Oslo, 0310
    Norway

    Site Not Available

    3,872.73 miles

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

    3,881.98 miles

  • UMC Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

    3,889.99 miles

  • Stichting Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

    3,897.66 miles

  • CHU de Toulouse - Hospital Rangueil

    Toulouse, 31400
    France

    Site Not Available

    3,933.59 miles

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

    3,949.11 miles

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

    3,953.71 miles

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

    4,011.71 miles

  • Centre Leon Berard

    Lyon, 69008
    France

    Site Not Available

    4,022.83 miles

  • Hospital de la Santa Creu i Sant Pau Barcelona

    Barcelona, 08041
    Spain

    Site Not Available

    4,032.97 miles

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908
    Spain

    Site Not Available

    4,032.97 miles

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

    4,032.97 miles

  • Medizinische Hochschule Hannover- Urology Oncology

    Hannover, 30625
    Germany

    Site Not Available

    4,034.06 miles

  • Universitaetsmedizin Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

    4,067.21 miles

  • AP-HM - Hôpital de la Timone

    Marseille, 13005
    France

    Site Not Available

    4,120.43 miles

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

    4,169.97 miles

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

    4,221.29 miles

  • Azienda Ospedaliero-Universitaria Careggi

    Rozzano, 50134
    Italy

    Active - Recruiting

    4,221.29 miles

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

    4,262.19 miles

  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

    Verona, 31726
    Italy

    Site Not Available

    4,298.44 miles

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, 85-796
    Poland

    Site Not Available

    4,320.4 miles

  • Centro Riferimento Oncologico - Aviano

    Aviano, 33081
    Italy

    Site Not Available

    4,344.81 miles

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Site Not Available

    4,344.84 miles

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola, 47014
    Italy

    Site Not Available

    4,387.52 miles

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej

    Gliwice, 44-102
    Poland

    Site Not Available

    4,442.96 miles

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

    Warsaw, 02-781
    Poland

    Site Not Available

    4,460.38 miles

  • Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika

    Debrecen, 4032
    Hungary

    Site Not Available

    4,658.47 miles

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127
    Italy

    Site Not Available

    4,660.82 miles

  • Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)

    Campinas, 130.83-888
    Brazil

    Site Not Available

    4,689.03 miles

  • Instituto Oncologico FALP

    Santiago, 7500921
    Chile

    Site Not Available

    5,013.82 miles

  • Centro de Oncologia de Precision, Universidad Mayor

    Santiago, 7560908
    Chile

    Site Not Available

    5,013.82 miles

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

    5,215.65 miles

  • Seoul National University Hosptial

    Seoul, 03080
    Korea, Republic of

    Site Not Available

    6,937.96 miles

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

    6,937.96 miles

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

    6,937.96 miles

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

    6,937.96 miles

  • Taipei Veterans General Hospital (VGHTP)

    Taipei, 11217
    Taiwan

    Site Not Available

    7,858.74 miles

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

    7,933.02 miles

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung, 83301
    Taiwan

    Site Not Available

    8,041.31 miles

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Site Not Available

    8,141.16 miles

  • lnstituto Nacional de Cancer - INCA

    Rio De Janeiro, 20.230-130
    Brazil

    Site Not Available

  • Masarykuv onkologicky ustav

    Brno, 65653
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc - Oncology clinic

    Olomouc, 77900
    Czechia

    Site Not Available

  • IRCCS La Fondazione e l'Istituto di Candiolo

    Candiolo, 10060
    Italy

    Site Not Available

  • Karolinska University Hospital

    Solna, 171 76
    Sweden

    Site Not Available

  • National Taiwan University Hospital

    New Taipei City, 10002
    Taiwan

    Site Not Available

  • Hong Kong United Oncology Centre

    Jordon,
    Hong Kong

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120
    Spain

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Humanity & Health Clinical Trial Centre

    Central,
    Hong Kong

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128
    Italy

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

    Montréal, HIT 2M4
    Canada

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Firenze, 47014
    Italy

    Active - Recruiting

  • Skane University Hospital Lund

    Lund, 22185
    Sweden

    Site Not Available

  • Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Bankstown-Lidcombe Hospital

    Bankstown, 2200
    Australia

    Site Not Available

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    São Paulo, 09060-650
    Brazil

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • Instituto Oncologico de Cordoba (IONC)

    Córdoba, X5000HWE
    Argentina

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526
    Germany

    Site Not Available

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200
    Poland

    Site Not Available

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