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A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 155 to 156
  2. Study sites: 153 to 155
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 13 entries
  3. Trial sites expanded: 124 → 153 locationsv9
  4. Trial sites expanded: 121 → 124 locations
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 13 entries
    v8
  5. Trial sites expanded: 84 → 121 locationsv7
  6. Trial sites expanded: 20 → 84 locationsv6
  7. Study sites: 14 to 20v5
  8. Study sites: 11 to 14v4
  9. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 3 to 11
    • Primary completion date: Jun 1, 2028 to May 30, 2028
    • Study completion date: Dec 3, 2030 to Nov 29, 2030
    • Start date changed from estimate of Dec 5, 2025 to Dec 3, 2025
  10. Start date: Oct 30, 2025 to Dec 5, 2025
    • Study sites: 0 to 3
    • Primary completion date: Apr 26, 2028 to Jun 1, 2028
    • Study completion date: Oct 28, 2030 to Dec 3, 2030
    v2
  11. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
246 trials monitored
See 20 trials at risk
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.
Trial Details
NCT Number NCT07218926
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Gastrointestinal Neoplasms
Related terms Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov