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A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Study acronym: INSIGHT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 52 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Feb 2026 to Dec 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2027 to Dec 2028
    • Site details revised at 70 of 70 sites
    v52
  2. Study sites: 69 to 70v51
  3. Study sites: 68 to 69v50
  4. Study sites: 66 to 68v49
  5. Study sites: 65 to 66v48
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 64 to 65v47
  2. Re-verified, no change to tracked fieldsv46
  3. Eligibility criteria shortened, about 24 wordsv45
  4. Study sites: 63 to 64v44
  5. Study sites: 62 to 63v43
  6. Study sites: 61 to 62v42
  7. Study sites: 60 to 61v41
  8. Study sites: 59 to 60v40
  9. Study sites: 58 to 59v39
  10. Study sites: 57 to 58v38
  11. Study sites: 56 to 57v37
  12. Study sites: 55 to 56v36
  13. Study sites: 54 to 55v35
  14. Study sites: 53 to 54v34
  15. Study sites: 51 to 53v33
  16. Study sites: 50 to 51v32
  17. Study sites: 49 to 50v31
  18. Study sites: 48 to 49v30
  19. Study sites: 46 to 48v29
  20. Study sites: 45 to 46v28
  21. Study sites: 44 to 45v27
  22. Study sites: 43 to 44v26
  23. Study sites: 42 to 43v25
  24. Study sites: 41 to 42v24
  25. Study sites: 40 to 41v23
  26. Study sites: 39 to 40v22
  27. Study sites: 38 to 39v21
  28. Study sites: 37 to 38v20
  29. Study sites: 36 to 37v19
  30. Study sites: 34 to 36v18
  31. Study sites: 32 to 34v17
  32. Study sites: 30 to 32v16
  33. Study sites: 27 to 30v15
  34. Study sites: 23 to 27v14
  35. Study sites: 20 to 23v13
  36. Study sites: 16 to 20
    • Start date changed from estimate of Dec 2023 to Dec 13, 2023
    v12
  37. Study sites: 15 to 16
    • Start date: Nov 2023 to Dec 2023
    v11
  38. Study sites: 13 to 15v10
  39. Study sites: 9 to 13v9
  40. Study sites: 6 to 9
    • Start date: Oct 2023 to Nov 2023
    v8
  41. Study sites: 5 to 6
    • Start date: Sep 2023 to Oct 2023
    v7
  42. Study sites: 4 to 5v6
  43. Study sites: 3 to 4
    • Start date: Aug 2023 to Sep 2023
    v5
  44. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v4
  45. Study title shortened, about 2 wordsv3
  • 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.
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.
Trial Details
NCT Number NCT05734105
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)		 GIST
Related terms Gastrointestinal Stromal Tumors
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov