search
Back to results

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

Primary Purpose

Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CGT9486 plus sunitinib
CGT9486
Sunitinib
Sunitinib
Sponsored by
Cogent Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastrointestinal Stromal Tumors focused on measuring Sunitinib, Solid Tumors, Gastrointestinal Stromal Tumors, Gastrointestinal, KIT, Kinase Inhibitors, Growth Inhibitors, CGT9486, Unresectable, Metastatic, GIST, Bezuclastinib, PLX9486

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. 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.
  2. Documented disease progression on or intolerance to imatinib

  3. Subjects must have received the following treatment:

    • 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
  5. ECOG - 0 to 2
  6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

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 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)

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Mayo ClinicRecruiting
  • University of Arizona- Cancer CenterRecruiting
  • City of HopeRecruiting
  • University of California, Los Angeles (UCLA)Recruiting
  • University of California, San Diego (UCSD)Recruiting
  • University of California, San FranciscoRecruiting
  • University of Colorado DenverRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Mayo Clinic JacksonvilleRecruiting
  • University of Miami - Sylvester Comprehensive Cancer CenterRecruiting
  • Mid Florida Hematology and Oncology CenterRecruiting
  • Orlando Health Cancer InstituteRecruiting
  • Moffitt Cancer CenterRecruiting
  • Northwestern UniversityRecruiting
  • University of Iowa Hospital and ClinicsRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • Mayo ClinicRecruiting
  • Washington UniversityRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Duke UniversityRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • The Ohio State University Comprehensive Cancer CenterRecruiting
  • University of Toledo Medical CenterRecruiting
  • Oregon Health & Science University (OHSU)Recruiting
  • Fox Chase Cancer CenterRecruiting
  • University of Pittsburgh Medical Center - Hillman Cancer CenterRecruiting
  • University of TennesseeRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • University of Wisconsin - Carbone Cancer CenterRecruiting
  • Instituto Alexander FlemingRecruiting
  • Instituto Oncologico de Cordoba (IONC)Recruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Bankstown-Lidcombe HospitalRecruiting
  • lnstituto Nacional de Cancer - INCARecruiting
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting
  • Princess Margaret HospitalRecruiting
  • Tom Baker Cancer CenterRecruiting
  • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)Recruiting
  • Instituto Oncologico FALPRecruiting
  • Centro de Oncologia de Precision, Universidad MayorRecruiting
  • Masarykuv onkologicky ustavRecruiting
  • Fakultni nemocnice Olomouc - Oncology clinicRecruiting
  • Aarhus University HospitalRecruiting
  • Institut BergonieRecruiting
  • Centre Oscar LambretRecruiting
  • Centre Leon BerardRecruiting
  • AP-HM - Hôpital de la TimoneRecruiting
  • Centre Eugene MarquisRecruiting
  • ICO St-HerblainRecruiting
  • CHU de Toulouse - Hospital RangueilRecruiting
  • Gustave RoussyRecruiting
  • Helios Klinikum Bad SaarowRecruiting
  • Helios Klinikum Berlin-BuchRecruiting
  • Medizinische Hochschule Hannover- Urology OncologyRecruiting
  • Humanity & Health Clinical Trial CentreRecruiting
  • Hong Kong United Oncology CentreRecruiting
  • Prince of Wales HospitalRecruiting
  • Debreceni Egyetem, Klinikai Központ, Onkológiai KlinikaRecruiting
  • ASST degli Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"Recruiting
  • Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
  • Policlinico Universitario Campus Bio-MedicoRecruiting
  • Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University HosptialRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Korea University Guro HospitalRecruiting
  • I Can Oncology Center SA De CVRecruiting
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)Recruiting
  • UMC GroningenRecruiting
  • Stichting Radboud Universitair Medisch CentrumRecruiting
  • Erasmus MCRecruiting
  • Haukeland University Hospital - BergenRecruiting
  • Oslo University HospitalRecruiting
  • Centrum Onkologii im. Prof. Franciszka LukaszczykaRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii DziennejRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Institut Catala d'Oncologia - L'HospitaletRecruiting
  • Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Hospital Fundación Jiménez DíazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Clinico Universitario de Santiago de CompostelaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Skane University Hospital LundRecruiting
  • Karolinska University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Taipei Veterans General Hospital (VGHTP)Recruiting
  • Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)Recruiting
  • Beatson, West of Scotland Cancer CentreRecruiting
  • University College London HospitalRecruiting
  • Guy's HospitalRecruiting
  • Royal Marsden Hospital - SurreyRecruiting
  • The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Part 1a

Part 2 - Experimental Group

Part 2 - Control Group

Part 1b - DDI Cohort 1

Part 1b - DDI Cohort 2

Arm Description

CGT9486 plus sunitinib 37.5 mg QD

CGT9486 plus sunitinib 37.5 mg QD

sunitinib 37.5 mg QD

CGT9486 plus sunitinib 37.5 mg QD

sunitinib 37.5 mg QD plus CGT9486

Outcomes

Primary Outcome Measures

Part 1a - pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Part 1a - pharmacokinetics - AUC
Area under the plasma concentration-time curve (AUC)
Part 1b - pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Part 1b - pharmacokinetics - AUC
Area under the plasma concentration-time curve (AUC)
Part 1b - pharmacokinetics - Tmax
Time to maximum observed plasma concentration (Tmax)
Part 2 - Progression Free Survival (PFS)
Time from first dose to documented disease progression or death due to any cause, whichever occurs first

Secondary Outcome Measures

All Study Parts - observing the safety of each treatment regimen.
Incidence and severity of Adverse Events from first dose of study drug
All Study Parts - observing the safety of each treatment regimen.
Incidence and severity of Serious Adverse Events from first dose of study drug
All Study Parts - observing the safety of each treatment regimen.
Incidence of Adverse Events leading to dose modifications from first dose of study drug
All Study Parts - observing the safety of each treatment regimen.
Change from baseline in laboratory results
All Study Parts - Overall Survival (OS)
Time from first dose to death due to any cause
All Study Parts - Objective Response Rate (ORR)
Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
All Study Parts - Disease Control Rate (DCR)
Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks
All Study Parts - Time to response (TTR)
Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1
All Study Parts - Duration of Response (DOR)
Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first
Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

Full Information

First Posted
December 23, 2021
Last Updated
October 11, 2023
Sponsor
Cogent Biosciences, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05208047
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cogent Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
Keywords
Sunitinib, Solid Tumors, Gastrointestinal Stromal Tumors, Gastrointestinal, KIT, Kinase Inhibitors, Growth Inhibitors, CGT9486, Unresectable, Metastatic, GIST, Bezuclastinib, PLX9486

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-part study: Part 1a is a single-arm design, Part 1b is a two-arm parallel design drug-drug interaction evaluation in the first treatment cycle and single-arm design in subsequent treatment cycles, and Part 2 is a randomized two-arm parallel comparator study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1a
Arm Type
Experimental
Arm Description
CGT9486 plus sunitinib 37.5 mg QD
Arm Title
Part 2 - Experimental Group
Arm Type
Experimental
Arm Description
CGT9486 plus sunitinib 37.5 mg QD
Arm Title
Part 2 - Control Group
Arm Type
Active Comparator
Arm Description
sunitinib 37.5 mg QD
Arm Title
Part 1b - DDI Cohort 1
Arm Type
Experimental
Arm Description
CGT9486 plus sunitinib 37.5 mg QD
Arm Title
Part 1b - DDI Cohort 2
Arm Type
Experimental
Arm Description
sunitinib 37.5 mg QD plus CGT9486
Intervention Type
Drug
Intervention Name(s)
CGT9486 plus sunitinib
Intervention Description
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Intervention Type
Drug
Intervention Name(s)
CGT9486
Intervention Description
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
sunitinib - Part 1b
Intervention Description
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
sunitinib - Part 2
Intervention Description
Participants will receive sunitinib orally until study stopping rules are met.
Primary Outcome Measure Information:
Title
Part 1a - pharmacokinetics - Cmax
Description
Maximum plasma concentration (Cmax)
Time Frame
16 days
Title
Part 1a - pharmacokinetics - AUC
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
16 days
Title
Part 1b - pharmacokinetics - Cmax
Description
Maximum plasma concentration (Cmax)
Time Frame
14 days
Title
Part 1b - pharmacokinetics - AUC
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
14 days
Title
Part 1b - pharmacokinetics - Tmax
Description
Time to maximum observed plasma concentration (Tmax)
Time Frame
14 days
Title
Part 2 - Progression Free Survival (PFS)
Description
Time from first dose to documented disease progression or death due to any cause, whichever occurs first
Time Frame
Approximately 48 months
Secondary Outcome Measure Information:
Title
All Study Parts - observing the safety of each treatment regimen.
Description
Incidence and severity of Adverse Events from first dose of study drug
Time Frame
Approximately 48 months
Title
All Study Parts - observing the safety of each treatment regimen.
Description
Incidence and severity of Serious Adverse Events from first dose of study drug
Time Frame
Approximately 48 months
Title
All Study Parts - observing the safety of each treatment regimen.
Description
Incidence of Adverse Events leading to dose modifications from first dose of study drug
Time Frame
Approximately 48 months
Title
All Study Parts - observing the safety of each treatment regimen.
Description
Change from baseline in laboratory results
Time Frame
Approximately 48 months
Title
All Study Parts - Overall Survival (OS)
Description
Time from first dose to death due to any cause
Time Frame
Approximately 48 months
Title
All Study Parts - Objective Response Rate (ORR)
Description
Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame
Approximately 48 months
Title
All Study Parts - Disease Control Rate (DCR)
Description
Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks
Time Frame
Approximately 48 months
Title
All Study Parts - Time to response (TTR)
Description
Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame
Approximately 48 months
Title
All Study Parts - Duration of Response (DOR)
Description
Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first
Time Frame
Approximately 48 months
Title
Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
Description
Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
Time Frame
Approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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: 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 ECOG - 0 to 2 Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits Key Exclusion Criteria: Known PDGFR driving mutations or known succinate dehydrogenase deficiency Clinically significant cardiac disease Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption Any active bleeding excluding hemorrhoidal or gum bleeding Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening Received strong CYP3A4 inhibitors or inducers Received sunitinib within 3 weeks (Part 1a, Part 1b)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cogent Biosciences
Phone
617-945-5576
Email
peakinfo@cogentbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Sachs, MD
Organizational Affiliation
Cogent Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arizona- Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Diego (UCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Florida Hematology and Oncology Center
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin - Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Name
Instituto Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Oncologico de Cordoba (IONC)
City
Córdoba
ZIP/Postal Code
X5000HWE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
ZIP/Postal Code
2200
Country
Australia
Individual Site Status
Recruiting
Facility Name
lnstituto Nacional de Cancer - INCA
City
Rio De Janeiro
ZIP/Postal Code
20.230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Center
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
City
Montréal
ZIP/Postal Code
HIT 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Instituto Oncologico FALP
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Centro de Oncologia de Precision, Universidad Mayor
City
Santiago
ZIP/Postal Code
7560908
Country
Chile
Individual Site Status
Recruiting
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc - Oncology clinic
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HM - Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Name
ICO St-Herblain
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Toulouse - Hospital Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Helios Klinikum Bad Saarow
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover- Urology Oncology
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Humanity & Health Clinical Trial Centre
City
Central
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Hong Kong United Oncology Centre
City
Jordon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
City
Verona
ZIP/Postal Code
31726
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hosptial
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
I Can Oncology Center SA De CV
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Stichting Radboud Universitair Medisch Centrum
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haukeland University Hospital - Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia - L'Hospitalet
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skane University Hospital Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
New Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital (VGHTP)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Beatson, West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital - Surrey
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs