A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib

Summary

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.

Eligibility

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.

Conditions2

Interventions1

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• A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline) — GlaxoSmithKline

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