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A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
Sponsor: GlaxoSmithKline
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-12-03
Completion Date
2030-11-29
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
IDRX-42
IDRX-42 will be administered.
Sunitinib
Sunitinib will be administered.
Locations (84)
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
Overland Park, Kansas, United States
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Boston, Massachusetts, United States
GSK Investigational Site
Boston, Massachusetts, United States
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Rochester, Minnesota, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Lake Success, New York, United States
GSK Investigational Site
New York, New York, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Tacoma, Washington, United States
GSK Investigational Site
Melbourne, Victoria, Australia
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Leuven, Belgium
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Barretos, São Paulo, Brazil
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Porto Alegre, Brazil
GSK Investigational Site
Recife, Brazil
GSK Investigational Site
Vitória, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
GSK Investigational Site
Jinan, China
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Bordeaux, France
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Lille, France
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Lyon, France
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Saint-Herblain, France
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Villejuif, France
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Berlin, Germany
GSK Investigational Site
Meldola, FC, Italy
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Candiolo, Italy
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Milan, Italy
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Palermo, Italy
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Roma, Italy
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Chiba, Japan
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Ehime, Japan
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Fukuoka, Japan
GSK Investigational Site
Hokkaido, Japan
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Kanagawa, Japan
GSK Investigational Site
Kumamoto, Japan
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Miyagi, Japan
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Osaka, Japan
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Tokyo, Japan
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Tokyo, Japan
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Nijmegen, Netherlands
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Oslo, Norway
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Kielce, Poland
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Poznan, Poland
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Warsaw, Poland
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Bucharest, Romania
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Craiova, Romania
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Timișoara, Romania
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Daegu, South Korea
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Seongnam-si Gyeonggi-do, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Suwon Kyunggi-do, South Korea
GSK Investigational Site
Yangsan, South Korea
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Oviedo, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Changhua, Taiwan
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taoyuan District, Taiwan
GSK Investigational Site
Cambridge, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
Manchester, United Kingdom
GSK Investigational Site
Sheffield, United Kingdom