Last updated 5 days ago
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
450 patients around the world
Available in United States, Brazil
GlaxoSmithKline
450Patients around the world
This study is for people with
Gastrointestinal stromal tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Gastrointestinal stromal tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07218926
