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
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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.
Participation Requirements View:
Inclusion Criteria
Exclusion Criteria
• 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.
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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
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Calgary
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Montreal
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Beijing
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Hangzhou
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Wuhan
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Angers
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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
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Berlin
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Essen
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Mannheim
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Ehime
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Fukuoka
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Miyagi
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Osaka
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Tokyo
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Nijmegen
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Oslo
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Kielce
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Poznan
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Warsaw
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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
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Bucharest
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Bucharest
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Craiova
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Timișoara
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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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Changhua
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Kaohsiung City
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Taipei
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Taipei
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Taoyuan
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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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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
Start Date: 2025-12-03
Estimated Completion Date: 2030-11-29
Target number of participants: 450
Experimental: IDRX-42 (GSK6042981)
Active_comparator: Sunitinib