Spots Global Cancer Trial Database for (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
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Trial Identification
Brief Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Official Title: A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Study ID: NCT05208047
Study Description
Brief 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 426 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 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Saint 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), Montréal, , 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
Medizinische Hochschule Hannover- Urology Oncology, Hannover, , 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, Sha Tin, , 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, Firenze, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , 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
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hosptial, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Centro de Investigacion Medica Aquascalientes (CIMA), Aguascalientes, , Mexico
I Can Oncology Center SA De CV, Monterrey, , Mexico
Oaxaca Site Management Organization S.C., Oaxaca, , 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
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, Sevilla, , 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, , 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, , 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
Contact Details
Name: Jessica Sachs, MD
Affiliation: Cogent Biosciences
Role: STUDY_DIRECTOR
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