NCT07218926 A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
| NCT ID | NCT07218926 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Condition | Gastrointestinal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2028-05-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion 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. * 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: * Known untreated or active central nervous system metastases. * 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 carci