Gastrointestinal Stromal Tumor Clinical Trials

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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 (123) 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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

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.

• Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.

• Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.

Locations
United States
Arizona
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Phoenix
California
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La Jolla
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Los Angeles
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San Francisco
Connecticut
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New Haven
Florida
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Jacksonville
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Miami
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Orlando
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Tampa
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
Michigan
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Ann Arbor
Minnesota
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Rochester
Missouri
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St Louis
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
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New York
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Rochester
Ohio
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Columbus
Oregon
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Portland
Pennsylvania
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Philadelphia
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Philadelphia
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Pittsburgh
South Carolina
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Spartanburg
Tennessee
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Knoxville
Texas
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Dallas
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Houston
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Santa Monica
Utah
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Salt Lake City
Virginia
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Charlottesville
Washington
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Seattle
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Tacoma
Other Locations
Australia
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Garran
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Melbourne
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Westmead
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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São Caetano Do Sul
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Vitória
Canada
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Calgary
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Montreal
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Toronto
China
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Beijing
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Hangzhou
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Jinan
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Shanghai
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Shanghai
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Wuhan
France
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Angers
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Bordeaux
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Lille
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Lyon
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Marseille
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Saint-herblain
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Toulouse
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Villejuif
Germany
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Berlin
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Essen
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Mannheim
Hungary
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Pécs
Italy
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Bari
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Candiolo
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Genova
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Meldola
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Milan
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Milan
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Palermo
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Roma
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Rozzano Mi
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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Bucharest
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Craiova
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Timișoara
Spain
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Barcelona
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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
United Kingdom
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Cambridge
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Edinburgh
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Leeds
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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

This content was sourced from clinicaltrials.gov

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