The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.
Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
Documented mutation status of KIT and/or PDGFRA.
Tumor tissue may be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Investigators may consult with the sponsor regarding the enrolment of participants for whom archival tissue is no longer available and who are not eligible to undergo a new biopsy.
Known untreated or active central nervous system metastases.
Has significant, uncontrolled, or active cardiovascular disease.
Participants with a known allergy or hypersensitivity to any component of velzatinib. 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.
Single group
Velzatinib
DrugVelzatinib will be administered.
Confirmed objective response rate (ORR)
ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).
Duration of response (DOR)
DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented disease progression (PD) or death due to any cause, whichever comes first.
Disease control rate for minimum 8-week period (DCR8)
DCR8 is defined as the percent of participants reaching confirmed CR or PR, or stable disease (SD) sustained for a minimum period of 8 weeks.
Progression free survival (PFS)
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death due to any cause, whichever comes first.
Overall survival (OS)
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
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