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. 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.
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. * 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. Exclusion Criteria: * GIST that is both KIT and PDGFRA wild-type or known…
Interventions
- DrugIDRX-42
IDRX-42 will be administered.
- DrugSunitinib
Sunitinib will be administered.
Locations (124)
- GSK Investigational SitePhoenix, Arizona
- GSK Investigational SiteLa Jolla, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteSan Francisco, California
- GSK Investigational SiteNew Haven, Connecticut
- GSK Investigational SiteJacksonville, Florida