A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
• Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
• Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.
Locations
United States
Arizona
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Phoenix
Florida
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Jacksonville
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Orlando
Iowa
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Iowa City
Kansas
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Overland Park
Massachusetts
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Boston
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Boston
Minnesota
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Rochester
North Carolina
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Durham
Nebraska
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Omaha
New York
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Lake Success
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New York
Pennsylvania
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Philadelphia
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Philadelphia
Tennessee
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Knoxville
Texas
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Dallas
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Houston
Washington
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Tacoma
Other Locations
Australia
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Melbourne
Belgium
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Leuven
Brazil
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Barretos
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Porto Alegre
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Recife
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Vitória
Canada
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Montreal
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Toronto
China
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Beijing
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Jinan
France
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Bordeaux
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Lille
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Lyon
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Saint-herblain
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Villejuif
Germany
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Berlin
Italy
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Candiolo
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Meldola
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Milan
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Palermo
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Roma
Japan
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Chiba
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Ehime
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Fukuoka
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Hokkaido
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Kanagawa
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Kumamoto
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Miyagi
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Osaka
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Tokyo
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Tokyo
Netherlands
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Nijmegen
Norway
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Oslo
Poland
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Kielce
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Poznan
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Warsaw
Republic of Korea
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Daegu
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Seongnam-si Gyeonggi-do
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon Kyunggi-do
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Yangsan
Romania
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Bucharest
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Craiova
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Timișoara
Spain
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Barcelona
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Madrid
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Madrid
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Oviedo
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Seville
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Valencia
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Zaragoza
Taiwan
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Changhua
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Kaohsiung City
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Kaohsiung City
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Taipei
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Taipei
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Taoyuan District
United Kingdom
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Cambridge
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London
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London
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Manchester
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Sheffield
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2030-11-29
Participants
Target number of participants: 450
Treatments
Experimental: IDRX-42 (GSK6042981)
Active_comparator: Sunitinib
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline