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Inclusion Criteria:

* 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.
* Is willing to use adequate contraception male and/or female participants.

Exclusion Criteria:

* 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.
* Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
* Is pregnant or breastfeeding.
* Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.

• Fukuoka, Japan
• Hokkaido, Japan