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A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

Study acronym: INTRIGUE
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Dec 2025 to Dec 2026v31
  2. Study completion date: Dec 2024 to Dec 2025v30
  3. Results first posted: Jan 2, 2024v29 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Start date: Feb 11, 2019 to Feb 8, 2019
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (4)
    • Study title revised
  4. Primary endpoints: 1 to 2v28 Show 5 more changesShow less
    • Enrollment target: estimated 426 to confirmed 453
    • Primary completion date changed from estimate of Jun 2021 to Sep 1, 2021
    • Study completion date: Mar 2022 to Dec 2024
    • Interventions: DCC-2618 (Drug), Sunitinib (Drug) to Ripretinib (Drug), Sunitinib (Drug)
    • Secondary endpoints: 2 to 4
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 122 to 121
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Site details revised at 4 of 122 sitesv26
  2. Site contacts updated at 1 of 122 sitesv25
  3. Study sites: 116 to 122v24
  4. Enrollment target: 358 to 426
    • Study sites: 106 to 116
    • Eligibility criteria expanded, about 31 words
    v23
  5. Study sites: 102 to 106v22
  6. Site details revised at 2 of 102 sitesv21
  7. Study sites: 90 to 102
    • Interventions: Sunitinib (Drug), ripretinib (Drug) to DCC-2618 (Drug), Sunitinib (Drug)
    • Eligibility criteria expanded, about 12 words
    v20
  8. Study sites: 85 to 90v19
  9. Study sites: 83 to 85v18
  10. Study sites: 59 to 83v17
  11. Study sites: 58 to 59
    • Interventions: DCC-2618 (Drug), Sunitinib (Drug) to Sunitinib (Drug), ripretinib (Drug)
    v16
  12. Study sites: 56 to 58v15
  13. Study sites: 45 to 56v14
  14. Study sites: 32 to 45v13
  15. Study sites: 26 to 32v12
  16. Study sites: 20 to 26v11
  17. Study sites: 16 to 20v10
  18. Study sites: 10 to 16v9
  19. Study sites: 7 to 10v8
  20. Study sites: 5 to 7v7
  21. Study sites: 3 to 5v6
  22. Study sites: 2 to 3
    • Start date changed from estimate of Jan 2019 to Feb 11, 2019
    v5
  23. Study sites: 1 to 2
    • Start date: Dec 2018 to Jan 2019
    v4
  24. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  25. Eligibility criteria shortened, about 23 wordsv2
  1. 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.
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Trial Details
NCT Number NCT03673501
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)		 Gastrointestinal Stromal Tumors
Related terms Gastrointestinal Stromal Tumors
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov