Gastrointestinal Stromal Tumors
Conditions
Interventions
- IDRX-42 (GSK6042981)
- Sunitinib
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion 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
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 carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS by BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| - OS - PFS by investigator - ORR - Time to Response - PFS2 - QoL - PK - Safety | — |
Countries
Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Romania, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed