NCT07689201 A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib
| NCT ID | NCT07689201 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Condition | Gastrointestinal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-08-17 |
| Primary Completion | 2027-11-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2026-08-17 with a primary completion date of 2027-11-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07689201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07689201 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07689201 currently recruiting?
Yes, NCT07689201 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07689201 trial being conducted?
This trial is being conducted at Fukuoka, Japan, Hokkaido, Japan.
Who is sponsoring the NCT07689201 clinical trial?
NCT07689201 is sponsored by GlaxoSmithKline. The trial plans to enroll 24 participants.