A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
NCT ID: NCT07218926
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-12-03
2030-11-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDRX-42 (GSK6042981)
IDRX-42
IDRX-42 will be administered.
Sunitinib
Sunitinib
Sunitinib will be administered.
Interventions
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IDRX-42
IDRX-42 will be administered.
Sunitinib
Sunitinib will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Knoxville, Tennessee, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Tacoma, Washington, United States
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
London, , United Kingdom
Countries
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Central Contacts
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EU GSK Clinical Trials Call Center
Role: CONTACT
Phone: +44 (0) 20 89904466
Email: [email protected]
Facility Contacts
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US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
Other Identifiers
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2025-522229-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
300383
Identifier Type: -
Identifier Source: org_study_id