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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)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 58 → 72 locations
  2. Trial sites expanded: 17 → 58 locations Eligibility criteria expanded, about 42 words · Secondary endpoints: details revised at 5 of 16 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 5 of 16 entries
  3. Recruitment opened Trial sites expanded: 2 → 17 locations · Primary completion date: Sep 6, 2032 to Aug 30, 2032 · Completion date: Oct 5, 2032 to Sep 28, 2032 · 1 morev3 Show 4 more changesShow less
    • Trial sites expanded: 2 → 17 locations
    • Primary completion date: Sep 6, 2032 to Aug 30, 2032
    • Completion date: Oct 5, 2032 to Sep 28, 2032
    • Start date changed from estimate of Jul 10, 2026 to Jul 27, 2026
  4. Study sites: 0 to 2 Primary completion date: Aug 30, 2032 to Sep 6, 2032 · Completion date: Sep 28, 2032 to Oct 5, 2032 · Start date: Jun 15, 2026 to Jul 10, 2026v2 Show 3 more changesShow less
    • Primary completion date: Aug 30, 2032 to Sep 6, 2032
    • Completion date: Sep 28, 2032 to Oct 5, 2032
    • Start date: Jun 15, 2026 to Jul 10, 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
245 trials monitored
See 20 trials at risk
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.
Trial Details
NCT Number NCT07585266
Lead Sponsor GlaxoSmithKline
Conditions Gastrointestinal Stromal Neoplasms
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov