TRIAL DETAIL

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

Drug:
Trial Name:
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 01/27/2022
Age of Trial (yrs) 1.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT inhibitor
Strategy:
Inhibit all resistant KIT/PDGFRa mutations
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CGT9486-21-301 Peak
Sponsor:
Cogent Biosciences, Inc.
Patient Contact:
Shaun Mitchell 973-220-4291 shaunica.mitchell@cogentbio.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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 388 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 multiple prior lines of therapy and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior lines of therapy. The second part of the study will enroll up to 350 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.

Partial Eligibility Criteria - Check full criteria in the NCT listing:

Key Inclusion Criteria:

Histologically confirmed locally advanced, metastatic, and/or unresectable GIST
Documented disease progression on or intolerance to imatinib
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:

Prior treatment with < 2 Tyrosine Kinase Inhibitors (TKIs) (Part 1b only)
Prior treatment with any TKI other than imatinib (Part 2 only)
Known PDGFR alpha D842V mutation or known succinate dehydrogenase deficiency ...
......

Trial Links

Trial Results

Drug Information

AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics - Corporate Presentation January 2022
 

Trial Sites

Name
Address
City
State
Zip
Country
Orange City
FL
32763
USA
Toledo
OH
43614
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
Washington
DC
20010
USA
1475 Northwest 12th Ave
Miami
FL
33136
USA
Orlando
FL
32806
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
2220 Pierce Ave.
Nashville
TN
37232
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
675 North St. Clair
Chicago
IL
60611
USA
1802 6th Ave. South
Birmingham
AL
35294
USA
Scottsdale
AZ
85259
USA
Santa Monica
CA
90404
USA
La Jolla
CA
92093
USA
Jacksonville
FL
32224
USA
12902 Magnolia Dr.
Tampa
FL
33612
USA
Iowa City
IA
52242
USA
Rochester
MN
55905
USA
Buffalo
NY
14263
USA
1275 York Ave
New York
NY
10065
USA
Durham
NC
27705
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
Pittsburgh
PA
15232
USA
Seattle
WA
98109
USA
Madison
WI
53792
USA
Hospital Avenue
Nedlands
Western Australia
6009
Australia
610 University Ave
Toronto
ON
M5G 2M9
Canada
Arhus
8000
Denmark
229 Cours Argonne
Bordeaux
Gironde
33076
France
Lille
Nord
59020
France
Lyon
69008
France
Marseille
13000
France
Rennes
35042
France
Saint-Herblain
Loire Atlantique
44805
France
Toulouse
Haut-Garonne
31059
France
Villejuif
Val de Narne
94805
France
Pieskower Straße 33
Bad Saarow
15526
Germany
Schwanebecker Chaussee
Berlin
Germany
Hannover
30625
Germany
Debrecen
Hungary
Goyang
410-768
Republic of Korea
101 DAEHAK-RO
Seoul
110-774
Republic of Korea
Seoul
Songpa-gu
138-736
Republic of Korea
Seoul
Republic of Korea
Groningen
9713 GZ
Netherlands
Nijmegen
Gelderland
6525 GH
Netherlands
Bergen
N-5021
Norway
Oslo
0424
Norway
Barcelona
08035
Spain
Madrid
Spain
Madrid
28040
Spain
Lund
SE-221 85
Sweden
Solna
SE-171 76
Sweden
Taipei
Taiwan
Taichung
Taiwan
1665 N. Ursula St.
Aurora
CO
80045
USA
3838 N. Campbell Ave
Tucson
AZ
85719
USA
San Francisco
CA
94158
USA
4001 Rainbow Blvd.
Kansas City
KS
66160
USA
Knoxville
TN
37920
USA
Bankstown
2200
Australia
Sao Paulo
09060-650
Brazil
Santiago
7560908
Chile
Hong Kong
China
Hong Kong
China
Hong Kong
China
Firenze
47014
Italy
Seoul
08308
Republic of Korea
Santiago de Compostela
15706
Spain
New Taipei City
10002
Taiwan
Rozzano
50134
Italy
Columbus
OH
43210
USA
Palermo
90127
Italy
Amsterdam
1066 CX
Netherlands
Madrid
Spain
Solna
SE-171 76
Sweden
Buenos Aires
C1426ANZ
Argentina
Verona
31726
Italy
Bydgoszcz
85-796
Poland