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)
GlaxoSmithKline
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugIDRX-42
IDRX-42 will be administered.
- DrugSunitinib
Sunitinib will be administered.
Locations (84)
- GSK Investigational SitePhoenix, Arizona
- GSK Investigational SiteJacksonville, Florida
- GSK Investigational SiteOrlando, Florida
- GSK Investigational SiteIowa City, Iowa
- GSK Investigational SiteOverland Park, Kansas
- GSK Investigational SiteBoston, Massachusetts