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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05208047

Studienbeginn:
April 2022

Letztes Update:
04.04.2024

Wirkstoff:
CGT9486 plus sunitinib, CGT9486, Sunitinib

Indikation (Clinical Trials):
Gastrointestinal Stromal Tumors

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Cogent Biosciences, Inc.

Collaborator:
-

Studienleiter

Jessica Sachs, MD
Study Director
Cogent Biosciences

Kontakt

Studienlocations
(3 von 123)

Helios Klinikum Bad Saarow
15526 Bad Saarow
(Brandenburg)
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Helios Klinikum Berlin-Buch
13125 Berlin
(Berlin)
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Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
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Medizinische Hochschule Hannover- Urology Oncology
30625 Hannover
(Niedersachsen)
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Universitaetsmedizin Mannheim
68167 Mannheim
(Baden-Württemberg)
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University of Alabama at Birmingham
35249 Birmingham
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University of Arizona- Cancer Center
85719 Tucson
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University of California, Los Angeles (UCLA)
90404 Los Angeles
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University of California, San Diego (UCSD)
92093 San Diego
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University of California, San Francisco
94158 San Francisco
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University of Colorado Denver
80204 Denver
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MedStar Washington Hospital Center
20010 Washington
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Mayo Clinic Jacksonville
32224 Jacksonville
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University of Miami - Sylvester Comprehensive Cancer Center
33136 Miami
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Mid Florida Hematology and Oncology Center
32763 Orange City
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Orlando Health Cancer Institute
32806 Orlando
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Northwestern University
60611 Chicago
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University of Iowa Hospital and Clinics
52242 Iowa City
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University of Kansas Cancer Center
66160 Kansas City
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Dana-Farber Cancer Institute
02115 Boston
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University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
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Washington University
63130 Saint Louis
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Nebraska Methodist Hospital
68114 Omaha
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Roswell Park Comprehensive Cancer Center
14203 Buffalo
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Memorial Sloan Kettering Cancer Center
10021 New York
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The Cleveland Clinic Foundation
44195 Cleveland
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The Ohio State University Comprehensive Cancer Center
43210 Columbus
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University of Toledo Medical Center
43614 Toledo
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Oregon Health & Science University (OHSU)
97239 Portland
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Fox Chase Cancer Center
19111 Philadelphia
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University of Pittsburgh Medical Center - Hillman Cancer Center
15232 Pittsburgh
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University of Tennessee
37920 Knoxville
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Vanderbilt University Medical Center
37232 Nashville
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The University of Texas MD Anderson Cancer Center
77030-4009 Houston
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Fred Hutchinson Cancer Center
98109 Seattle
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University of Wisconsin - Carbone Cancer Center
53705 Madison
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Instituto Alexander Fleming
C1426ANZ Buenos Aires
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Instituto Oncologico de Cordoba (IONC)
X5000HWE Córdoba
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Sir Charles Gairdner Hospital
6009 Nedlands
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Bankstown-Lidcombe Hospital
2200 Bankstown
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Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
130.83-888 Campinas
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lnstituto Nacional de Cancer - INCA
20.230-130 Rio De Janeiro
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CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
09060-650 São Paulo
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Alberta Health Services Cross Cancer Institute
T6G 1Z2 Edmonton
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Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
HIT 2M4 Montréal
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Centro de Oncologia de Precision, Universidad Mayor
7560908 Santiago
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Fakultni nemocnice Hradec Kralove
500 05 Hradec Králové
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Fakultni nemocnice Olomouc - Oncology clinic
77900 Olomouc
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AP-HM - Hôpital de la Timone
13005 Marseille
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CHU de Toulouse - Hospital Rangueil
31400 Toulouse
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Humanity & Health Clinical Trial Centre
Central
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Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
4032 Debrecen
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Centro Riferimento Oncologico - Aviano
33081 Aviano
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IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
40138 Bologna
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ASST degli Spedali Civili di Brescia
25123 Brescia
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IRCCS La Fondazione e l'Istituto di Candiolo
10060 Candiolo
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Azienda Ospedaliero-Universitaria Careggi
50134 Firenze
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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
47014 Meldola
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Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
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Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
90127 Palermo
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Policlinico Universitario Campus Bio-Medico
00128 Roma
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Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
31726 Verona
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National Cancer Center
10408 Goyang-si
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Seoul National University Hosptial
03080 Seoul
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Asan Medical Center
05505 Seoul
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Samsung Medical Center
06351 Seoul
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Korea University Guro Hospital
08308 Seoul
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Centro de Investigacion Medica Aquascalientes (CIMA)
20116 Aguascalientes
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I Can Oncology Center SA De CV
64710 Monterrey
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Oaxaca Site Management Organization S.C.
68000 Oaxaca
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
1066 CX Amsterdam
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Stichting Radboud Universitair Medisch Centrum
6525 GA Nijmegen
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Haukeland University Hospital - Bergen
5021 Bergen
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Szpital Specjalistyczny w Brzozowie
36-200 Brzozów
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Centrum Onkologii im. Prof. Franciszka Lukaszczyka
85-796 Bydgoszcz
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
44-102 Gliwice
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
02-781 Warsaw
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Hospital Universitario Vall d'Hebron
08035 Barcelona
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Hospital de la Santa Creu i Sant Pau Barcelona
08041 Barcelona
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Institut Catala d'Oncologia - L'Hospitalet
08908 Barcelona
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Hospital Clinico Universitario Virgen de la Arrixaca
30120 El Palmar
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Hospital General Universitario Gregorio Maranon
28007 Madrid
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Hospital Fundación Jiménez Díaz
28040 Madrid
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Hospital Universitario 12 de Octubre
28041 Madrid
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Hospital Clinico Universitario de Santiago de Compostela
15706 Santiago De Compostela
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Hospital Universitario Virgen del Rocio
41013 Sevilla
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Hospital Universitario Miguel Servet
50009 Zaragoza
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Karolinska University Hospital
171 76 Solna
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Chang Gung Memorial Hospital - Kaohsiung Branch
83301 Kaohsiung
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National Taiwan University Hospital
10002 New Taipei City
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China Medical University Hospital
40447 Taichung
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Taipei Veterans General Hospital (VGHTP)
11217 Taipei
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Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)
33305 Taoyuan
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Beatson, West of Scotland Cancer Centre
G12 0YN Glasgow
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University College London Hospital
NW1 2PG London
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Royal Marsden Hospital - Surrey
SW3 6JJ London
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The Christie NHS Foundation Trust
M20 4BX Manchester
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Part 1a - pharmacokinetics - Cmax (Time Frame - 16 days):
Maximum plasma concentration (Cmax)

2. Part 1a - pharmacokinetics - AUC (Time Frame - 16 days):
Area under the plasma concentration-time curve (AUC)

3. Part 1b - pharmacokinetics - Cmax (Time Frame - 14 days):
Maximum plasma concentration (Cmax)

4. Part 1b - pharmacokinetics - AUC (Time Frame - 14 days):
Area under the plasma concentration-time curve (AUC)

5. Part 1b - pharmacokinetics - Tmax (Time Frame - 14 days):
Time to maximum observed plasma concentration (Tmax)

6. Part 2 - Progression Free Survival (PFS) (Time Frame - Approximately 48 months):
Time from first dose to documented disease progression or death due to any cause, whichever occurs first

Secondary outcome:

1. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months):
Incidence and severity of Adverse Events from first dose of study drug

2. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months):
Incidence and severity of Serious Adverse Events from first dose of study drug

3. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months):
Incidence of Adverse Events leading to dose modifications from first dose of study drug

4. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months):
Change from baseline in laboratory results

5. All Study Parts - Overall Survival (OS) (Time Frame - Approximately 48 months):
Time from first dose to death due to any cause

6. All Study Parts - Objective Response Rate (ORR) (Time Frame - Approximately 48 months):
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

7. All Study Parts - Disease Control Rate (DCR) (Time Frame - Approximately 48 months):
Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks

8. All Study Parts - Time to response (TTR) (Time Frame - Approximately 48 months):
Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1

9. All Study Parts - Duration of Response (DOR) (Time Frame - Approximately 48 months):
Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first

10. Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30) (Time Frame - Approximately 48 months):
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.

Studien-Arme

  • 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

Geprüfte Regime

  • CGT9486 plus sunitinib:
    Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
  • CGT9486:
    Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
  • Sunitinib (sunitinib - Part 1b):
    Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
  • Sunitinib (sunitinib - Part 2):
    Participants will receive sunitinib orally until study stopping rules are met.

Quelle: ClinicalTrials.gov


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

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