(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

April 14, 2022

Primary Completion Date

July 31, 2025

Study Completion Date

September 30, 2026

Conditions
Advanced Gastrointestinal Stromal TumorsMetastatic Cancer
Interventions
DRUG

CGT9486 plus sunitinib

Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.

DRUG

CGT9486

Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.

DRUG

Sunitinib

Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.

DRUG

Sunitinib

Participants will receive sunitinib orally until study stopping rules are met.

DRUG

Midazolam

Participants will receive a single-dose of midazolam on Day 1 and Day 16

DRUG

CGT9486 plus sunitinib

Patients will receive CGT9486 orally starting on Day 2 and sunitinib starting on Day 16 until study stopping rules are met.

Trial Locations (126)

2200

Bankstown-Lidcombe Hospital, Bankstown

4032

Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika, Debrecen

5021

Haukeland University Hospital - Bergen, Bergen

6009

Sir Charles Gairdner Hospital, Nedlands

8200

Aarhus University Hospital, Aarhus

10002

National Taiwan University Hospital, New Taipei City

10021

Memorial Sloan Kettering Cancer Center, New York

10060

IRCCS La Fondazione e l'Istituto di Candiolo, Candiolo

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital (VGHTP), Taipei

13005

AP-HM - Hôpital de la Timone, Marseille

13125

Helios Klinikum Berlin-Buch, Berlin

14203

Roswell Park Comprehensive Cancer Center, Buffalo

15232

University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh

15526

Helios Klinikum Bad Saarow, Bad Saarow

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

19111

Fox Chase Cancer Center, Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

20116

Centro de Investigacion Medica Aquascalientes (CIMA), Aguascalientes

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

22185

Skane University Hospital Lund, Lund

25123

ASST degli Spedali Civili di Brescia, Brescia

27705

Duke University, Durham

28007

Hospital General Universitario Gregorio Maranon, Madrid

28040

Hospital Clinico San Carlos, Madrid

Hospital Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

30625

Medizinische Hochschule Hannover- Urology Oncology, Hanover

31400

CHU de Toulouse - Hospital Rangueil, Toulouse

31726

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento, Verona

32224

Mayo Clinic Jacksonville, Jacksonville

32763

Mid Florida Hematology and Oncology Center, Orange City

32806

Orlando Health Cancer Institute, Orlando

33076

Institut Bergonie, Bordeaux

33081

Centro Riferimento Oncologico - Aviano, Aviano

33136

University of Miami - Sylvester Comprehensive Cancer Center, Miami

33305

Chang Gung Memorial Hospital - Linkou Branch (CGMHLK), Taoyuan District

33612

Moffitt Cancer Center, Tampa

35042

Centre Eugene Marquis, Rennes

35249

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

37920

University of Tennessee, Knoxville

40138

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

40447

China Medical University Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

43210

The Ohio State University Comprehensive Cancer Center, Columbus

43614

University of Toledo Medical Center, Toledo

44195

The Cleveland Clinic Foundation, Cleveland

44800

ICO St-Herblain, Saint-Herblain

45147

Universitaetsklinikum Essen, Essen

47014

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori", Meldola

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

50009

Hospital Universitario Miguel Servet, Zaragoza

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

52242

University of Iowa Hospital and Clinics, Iowa City

53705

University of Wisconsin - Carbone Cancer Center, Madison

55905

Mayo Clinic, Rochester

59000

Centre Oscar Lambret, Lille

60611

Northwestern University, Chicago

63130

Washington University, St Louis

64710

I Can Oncology Center SA De CV, Monterrey

65653

Masarykuv onkologicky ustav, Brno

66160

University of Kansas Cancer Center, Kansas City

68000

Oaxaca Site Management Organization S.C., Oaxaca City

68114

Nebraska Methodist Hospital, Omaha

68167

Universitaetsmedizin Mannheim, Mannheim

69008

Centre Leon Berard, Lyon

77900

Fakultni nemocnice Olomouc - Oncology clinic, Olomouc

80204

University of Colorado Denver, Denver

83301

Chang Gung Memorial Hospital - Kaohsiung Branch, Kaohsiung City

85259

Mayo Clinic, Scottsdale

85719

University of Arizona- Cancer Center, Tucson

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

90404

University of California, Los Angeles (UCLA), Los Angeles

91010

City of Hope, Duarte

92093

University of California, San Diego (UCSD), San Diego

94158

University of California, San Francisco, San Francisco

94805

Gustave Roussy, Villejuif

97239

Oregon Health & Science University (OHSU), Portland

98109

Fred Hutchinson Cancer Center, Seattle

7500921

Instituto Oncologico FALP, Santiago

7560908

Centro de Oncologia de Precision, Universidad Mayor, Santiago

02115

Dana-Farber Cancer Institute, Boston

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

C1426ANZ

Instituto Alexander Fleming, Buenos Aires

X5000HWE

Instituto Oncologico de Cordoba (IONC), Córdoba

130.83-888

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

20.230-130

lnstituto Nacional de Cancer - INCA, Rio de Janeiro

09060-650

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, São Paulo

T6G 1Z2

Alberta Health Services Cross Cancer Institute, Edmonton

M5G 2M9

Princess Margaret Hospital, Toronto

T2N 4N2

Tom Baker Cancer Center, Calgary

HIT 2M4

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

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

Unknown

Humanity & Health Clinical Trial Centre, Central

Hong Kong United Oncology Centre, Jordon

Prince of Wales Hospital, Shatin

00128

Policlinico Universitario Campus Bio-Medico, Roma

1066 CX

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

9713 GZ

UMC Groningen, Groningen

6525 GA

Stichting Radboud Universitair Medisch Centrum, Nijmegen

3015 GD

Erasmus MC, Rotterdam

0310

Oslo University Hospital, Oslo

36-200

Szpital Specjalistyczny w Brzozowie, Brzozów

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka, Bydgoszcz

44-102

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

02-781

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

03080

Seoul National University Hosptial, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitario Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona

08908

Institut Catala d'Oncologia - L'Hospitalet, Barcelona

171 76

Karolinska University Hospital, Solna

CB2 0QQ

Cambridge Addenbrooke's Hospital, Cambridge

G12 0YN

Beatson, West of Scotland Cancer Centre, Glasgow

NW1 2PG

University College London Hospital, London

SE1 9RT

Guy's Hospital, London

SW3 6JJ

Royal Marsden Hospital - Surrey, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

S10 2SJ

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

Sponsors
All Listed Sponsors
lead

Cogent Biosciences, Inc.

INDUSTRY