Trial NCT07218926
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
- Phase
- Phase 3
- Sponsor
- GlaxoSmithKline
- Conditions
- Gastrointestinal Neoplasms
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 to harbor an activating PDGFRA exon 18 mutation.
* Known untreated or active central nervous system metastases.Brain 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.Prior malignancy
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Prior malignancyConditionalexclusion
within 24 months
Show in the text
Recruiting in Massachusetts
- GSK Investigational Site · Boston, Suffolk County
- GSK Investigational Site · Boston, Suffolk County