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

Who is this study for? Patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors
Status: Active_not_recruiting
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Documented disease progression on or intolerance to imatinib

• 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

• Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)

• ECOG - 0 to 2

• Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Mayo Clinic
Scottsdale
University of Arizona- Cancer Center
Tucson
California
City of Hope
Duarte
University of California, Los Angeles (UCLA)
Los Angeles
University of California, San Diego (UCSD)
San Diego
University of California, San Francisco
San Francisco
Colorado
University of Colorado Denver
Denver
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Florida
Mayo Clinic Jacksonville
Jacksonville
University of Miami - Sylvester Comprehensive Cancer Center
Miami
Mid Florida Hematology and Oncology Center
Orange City
Orlando Health Cancer Institute
Orlando
Moffitt Cancer Center
Tampa
Iowa
University of Iowa Hospital and Clinics
Iowa City
Illinois
Northwestern University
Chicago
Kansas
University of Kansas Cancer Center
Kansas City
Massachusetts
Dana-Farber Cancer Institute
Boston
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Missouri
Washington University
St Louis
North Carolina
Duke University
Durham
Nebraska
Nebraska Methodist Hospital
Omaha
New York
Roswell Park Comprehensive Cancer Center
Buffalo
Memorial Sloan Kettering Cancer Center
New York
Ohio
The Cleveland Clinic Foundation
Cleveland
The Ohio State University Comprehensive Cancer Center
Columbus
University of Toledo Medical Center
Toledo
Oregon
Oregon Health & Science University (OHSU)
Portland
Pennsylvania
Fox Chase Cancer Center
Philadelphia
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh
Tennessee
University of Tennessee
Knoxville
Vanderbilt University Medical Center
Nashville
Texas
The University of Texas MD Anderson Cancer Center
Houston
Washington
Fred Hutchinson Cancer Center
Seattle
Wisconsin
University of Wisconsin - Carbone Cancer Center
Madison
Other Locations
Argentina
Instituto Alexander Fleming
Buenos Aires
Instituto Oncologico de Cordoba (IONC)
Córdoba
Australia
Bankstown-Lidcombe Hospital
Bankstown
Sir Charles Gairdner Hospital
Nedlands
Brazil
Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
Campinas
lnstituto Nacional de Cancer - INCA
Rio De Janeiro
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo
Canada
Tom Baker Cancer Center
Calgary
Alberta Health Services Cross Cancer Institute
Edmonton
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal
Princess Margaret Hospital
Toronto
Chile
Centro de Oncologia de Precision, Universidad Mayor
Santiago
Instituto Oncologico FALP
Santiago
Denmark
Aarhus University Hospital
Aarhus
France
Institut Bergonie
Bordeaux
Centre Oscar Lambret
Lille
Centre Leon Berard
Lyon
AP-HM - Hôpital de la Timone
Marseille
Centre Eugene Marquis
Rennes
ICO St-Herblain
Saint-herblain
CHU de Toulouse - Hospital Rangueil
Toulouse
Gustave Roussy
Villejuif
Germany
Helios Klinikum Bad Saarow
Bad Saarow
Helios Klinikum Berlin-Buch
Berlin
Universitaetsklinikum Essen
Essen
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover- Urology Oncology
Hanover
Universitaetsmedizin Mannheim
Mannheim
Hong Kong Special Administrative Region
Humanity & Health Clinical Trial Centre
Central
Hong Kong United Oncology Centre
Jordon
Prince of Wales Hospital
Shatin
Hungary
Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
Debrecen
Italy
Centro Riferimento Oncologico - Aviano
Aviano
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna
ASST degli Spedali Civili di Brescia
Brescia
IRCCS La Fondazione e l'Istituto di Candiolo
Candiolo
Azienda Ospedaliero-Universitaria Careggi
Florence
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Istituto Europeo di Oncologia
Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
Policlinico Universitario Campus Bio-Medico
Roma
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona
Mexico
Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes
I Can Oncology Center SA De CV
Monterrey
Oaxaca Site Management Organization S.C.
Oaxaca City
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam
UMC Groningen
Groningen
Stichting Radboud Universitair Medisch Centrum
Nijmegen
Erasmus MC
Rotterdam
Norway
Haukeland University Hospital - Bergen
Bergen
Oslo University Hospital
Oslo
Poland
Szpital Specjalistyczny w Brzozowie
Brzozów
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
Gliwice
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw
Republic of Korea
National Cancer Center
Goyang-si
Asan Medical Center
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hosptial
Seoul
Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Institut Catala d'Oncologia - L'Hospitalet
Barcelona
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar
Hospital Clinico San Carlos
Madrid
Hospital Fundación Jiménez Díaz
Madrid
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Clinico Universitario de Santiago de Compostela
Santiago De Compostela
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Miguel Servet
Zaragoza
Sweden
Skane University Hospital Lund
Lund
Karolinska University Hospital
Solna
Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City
National Taiwan University Hospital
New Taipei City
China Medical University Hospital
Taichung
Taipei Veterans General Hospital (VGHTP)
Taipei
Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)
Taoyuan District
United Kingdom
Cambridge Addenbrooke's Hospital
Cambridge
Beatson, West of Scotland Cancer Centre
Glasgow
Guy's Hospital
London
Royal Marsden Hospital - Surrey
London
University College London Hospital
London
The Christie NHS Foundation Trust
Manchester
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Time Frame
Start Date: 2022-04-14
Completion Date: 2026-09
Participants
Target number of participants: 442
Treatments
Experimental: Part 1a
CGT9486 plus sunitinib 37.5 mg QD
Experimental: Part 2 - Experimental Group
CGT9486 plus sunitinib 37.5 mg QD
Active_comparator: Part 2 - Control Group
sunitinib 37.5 mg QD
Experimental: Part 1b - DDI Cohort 1
CGT9486 plus sunitinib 37.5 mg QD
Experimental: Part 1b - DDI Cohort 2
sunitinib 37.5 mg QD plus CGT9486
Experimental: DDI Substudy (Midazolam)
Midazolam, CGT9486, sunitinib
Related Therapeutic Areas
Sponsors
Leads: Cogent Biosciences, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials