Drug: |
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Trial Name: |
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Recruiting |
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Phase: |
3 |
Start Date 01/27/2022 |
Age of Trial (yrs) 1.7 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT inhibitor |
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Strategy: |
Inhibit all resistant KIT/PDGFRa mutations |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
CGT9486-21-301
Peak |
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Sponsor: |
Cogent Biosciences, Inc. |
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Patient Contact: |
Shaun Mitchell
973-220-4291
shaunica.mitchell@cogentbio.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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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 |
Name |
Address |
City |
State |
Zip |
Country |
Orange City |
FL |
32763 |
USA |
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Toledo |
OH |
43614 |
USA |
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1500 E. Duarte Road |
Duarte |
CA |
91010 |
USA |
|
Washington |
DC |
20010 |
USA |
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1475 Northwest 12th Ave |
Miami |
FL |
33136 |
USA |
|
Orlando |
FL |
32806 |
USA |
||
1500 East Medical Center Dr |
Ann Arbor |
MI |
48109 |
USA |
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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 |
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Santa Monica |
CA |
90404 |
USA |
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La Jolla |
CA |
92093 |
USA |
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Jacksonville |
FL |
32224 |
USA |
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12902 Magnolia Dr. |
Tampa |
FL |
33612 |
USA |
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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 |
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3181 S.W. Sam Jackson Park Rd. |
Portland |
OR |
97239 |
USA |
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Pittsburgh |
PA |
15232 |
USA |
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Seattle |
WA |
98109 |
USA |
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Madison |
WI |
53792 |
USA |
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Hospital Avenue |
Nedlands |
Western Australia |
6009 |
Australia |
|
610 University Ave |
Toronto |
ON |
M5G 2M9 |
Canada |
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Arhus |
8000 |
Denmark |
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229 Cours Argonne |
Bordeaux |
Gironde |
33076 |
France |
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Lille |
Nord |
59020 |
France |
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Lyon |
69008 |
France |
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Marseille |
13000 |
France |
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Rennes |
35042 |
France |
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Saint-Herblain |
Loire Atlantique |
44805 |
France |
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Toulouse |
Haut-Garonne |
31059 |
France |
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Villejuif |
Val de Narne |
94805 |
France |
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Pieskower Straße 33 |
Bad Saarow |
15526 |
Germany |
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Schwanebecker Chaussee |
Berlin |
Germany |
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Hannover |
30625 |
Germany |
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Debrecen |
Hungary |
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Goyang |
410-768 |
Republic of Korea |
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101 DAEHAK-RO |
Seoul |
110-774 |
Republic of Korea |
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Seoul |
Songpa-gu |
138-736 |
Republic of Korea |
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Seoul |
Republic of Korea |
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Groningen |
9713 GZ |
Netherlands |
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Nijmegen |
Gelderland |
6525 GH |
Netherlands |
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Bergen |
N-5021 |
Norway |
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Oslo |
0424 |
Norway |
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Barcelona |
08035 |
Spain |
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Madrid |
Spain |
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Madrid |
28040 |
Spain |
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Lund |
SE-221 85 |
Sweden |
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Solna |
SE-171 76 |
Sweden |
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Taipei |
Taiwan |
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Taichung |
Taiwan |
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1665 N. Ursula St. |
Aurora |
CO |
80045 |
USA |
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3838 N. Campbell Ave |
Tucson |
AZ |
85719 |
USA |
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San Francisco |
CA |
94158 |
USA |
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4001 Rainbow Blvd. |
Kansas City |
KS |
66160 |
USA |
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Knoxville |
TN |
37920 |
USA |
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Bankstown |
2200 |
Australia |
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Sao Paulo |
09060-650 |
Brazil |
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Santiago |
7560908 |
Chile |
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Hong Kong |
China |
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Hong Kong |
China |
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Hong Kong |
China |
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Firenze |
47014 |
Italy |
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Seoul |
08308 |
Republic of Korea |
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Santiago de Compostela |
15706 |
Spain |
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New Taipei City |
10002 |
Taiwan |
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Rozzano |
50134 |
Italy |
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Columbus |
OH |
43210 |
USA |
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Palermo |
90127 |
Italy |
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Amsterdam |
1066 CX |
Netherlands |
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Madrid |
Spain |
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Solna |
SE-171 76 |
Sweden |
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Buenos Aires |
C1426ANZ |
Argentina |
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Verona |
31726 |
Italy |
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Bydgoszcz |
85-796 |
Poland |