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NCT07585266 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Not yet
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
NCT07585266: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT07585266 is a Phase 3 study that has not yet begun recruiting, run by GlaxoSmithKline. The registered enrollment target is 800 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07585266, a Phase 3 study, has not yet begun recruiting, sponsored by GlaxoSmithKline.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Interventions
- DRUG Imatinib
- DRUG Velzatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2026-07-10 |
| Est. Completion | 2032-10-05 |
| Phase | Phase 3 |
What is known before NCT07585266 opens enrollment
NCT07585266 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Imatinib is the first listed.
NCT07585266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07585266 about?
NCT07585266 is a clinical study titled "A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)". 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 ...
What is the current status of trial NCT07585266?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2026-07-10. Estimated completion is 2032-10-05.
What interventions are being tested in trial NCT07585266?
The interventions under investigation include: Imatinib (DRUG), Velzatinib (DRUG).
Who is sponsoring clinical trial NCT07585266?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07585266's enrollment target sits among peer trials
800 414th of 2000 higher than 1,573 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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