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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 is a Phase 3 study that has not yet begun recruiting, run by GlaxoSmithKline. The registered enrollment target is 800 participants.

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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.

Interventions

  • DRUG Imatinib
  • DRUG Velzatinib

Trial Details

FieldValue
Enrollment Target 800 participants
Start Date 2026-07-10
Est. Completion 2032-10-05
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT07585266

The ClinicalTrials.gov registry entry for NCT07585266 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Imatinib is the first listed.

NCT07585266 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.