A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
Public ClinicalTrials.gov record NCT07585266. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Gastrointestinal Stromal Tumour (GIST) is a soft tissue tumour that develops in the digestive system, most often in the stomach or small intestine. It is caused by changes in certain proteins that cause the cells to grow uncontrollably. Although current treatments may be effective, tumours may stop responding over time, highlighting the need for newer options. This study is evaluating velzatinib (GSK6042981) in participants with newly diagnosed GIST that has spread or cannot be surgically removed. Velzatinib will be compared with imatinib, the standard treatment, to assess whether it can delay disease worsening and is safe and well tolerated.
Study identification
- NCT ID
- NCT07585266
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 27, 2026 (Actual)
- Primary completion
- Aug 30, 2032 (Estimated)
- Completion
- Sep 28, 2032 (Estimated)
- Last update posted
- Oct 23, 2026
2026 – 2032
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Scottsdale | Arizona | 85258 | Recruiting |
| GSK Investigational Site | San Francisco | California | 94158 | Recruiting |
| GSK Investigational Site | New Haven | Connecticut | 06510-3206 | Recruiting |
| GSK Investigational Site | Bethesda | Maryland | 20817-1802 | Recruiting |
| GSK Investigational Site | Kansas City | Missouri | 64132 | Recruiting |
| GSK Investigational Site | Omaha | Nebraska | 68130-2042 | Recruiting |
| GSK Investigational Site | New York | New York | 10065 | Recruiting |
| GSK Investigational Site | Durham | North Carolina | 27710 | Recruiting |
| GSK Investigational Site | Canton | Ohio | 44718 | Recruiting |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | Recruiting |
| GSK Investigational Site | Houston | Texas | 77030 | Recruiting |
| GSK Investigational Site | Seattle | Washington | 98109-4405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07585266, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07585266 live on ClinicalTrials.gov.