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(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Trial sites expanded: 110 → 126 locations
    • Interventions: CGT9486 (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), Midazolam (Drug), Sunitinib… to CGT9486 (Drug), CGT9486 (Drug), CGT9486 (Drug), CGT9486 (Drug), Midazolam (Drug), Sunitinib (Drug), Sunitinib (Drug), Sunitinib (Drug)…
    • Eligibility criteria expanded, about 9 words
    v47
  2. Study completion pushed from Sep 2026 to Jan 2030v46 Show 4 more changesShow less
    • Trial arms changed: 6 → 7
    • Enrollment target: 442 to 482
    • Interventions: CGT9486 (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), Midazolam (Drug), Sunitinib (Drug), Sunitinib (Drug) to CGT9486 (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), Midazolam (Drug), Sunitinib…
    • Eligibility criteria expanded, about 98 words
  3. Study sites: 126 to 110v45
  4. Primary completion date changed from estimate of Jul 2025 to Sep 30, 2025v44
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 126 of 126 sites
    v43
Show 41 earlier versionsHide 41 earlier versions
  1. Primary endpoints: 6 to 8v42 Show 6 more changesShow less
    • Enrollment target: 426 to 442
    • Interventions: CGT9486 (Drug), CGT9486 plus sunitinib (Drug), Sunitinib (Drug), Sunitinib (Drug) to CGT9486 (Drug), CGT9486 plus sunitinib (Drug), CGT9486 plus sunitinib (Drug), Midazolam (Drug), Sunitinib (Drug), Sunitinib (Drug)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (10)
    • Site details revised at 120 of 126 sites
    • Study arms: 5 to 6
  2. Study sites: 125 to 126v41
  3. Study sites: 124 to 125v40
  4. Study sites: 123 to 124v39
  5. Study sites: 122 to 123v38
  6. Study sites: 121 to 122v37
  7. Study sites: 115 to 121v36
  8. Study sites: 113 to 115v35
  9. Study sites: 106 to 113v34
  10. Study sites: 104 to 106v33
  11. Study sites: 95 to 104v32
  12. Study sites: 90 to 95v31
  13. Study sites: 85 to 90v30
  14. Study sites: 82 to 85v29
  15. Study sites: 76 to 82v28
  16. 2 versions Re-verified since Aug 11, 2023, no change to tracked fieldsv26-v27
  17. Study sites: 71 to 76v25
  18. Study sites: 65 to 71v24
  19. Study sites: 59 to 65v23
  20. Study sites: 54 to 59v22
  21. Study sites: 49 to 54v21
  22. Study sites: 35 to 49v20
  23. Study sites: 36 to 35v19
  24. Study sites: 33 to 36v18
  25. Study sites: 21 to 33v17
  26. Study sites: 18 to 21v16
  27. Study sites: 15 to 18v15
  28. Study sites: 14 to 15v14
  29. Study sites: 13 to 14v13
  30. Study sites: 12 to 13v12
  31. Study sites: 10 to 12v11
  32. Study sites: 8 to 10v10
  33. Start date: Jan 27, 2022 to Apr 14, 2022v9 Show 5 more changesShow less
    • Primary endpoints: 8 to 6
    • Enrollment target: 388 to 426
    • Primary completion date: Sep 2025 to Jul 2025
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 12 to 10
  34. Study sites: 7 to 8v8
  35. Site details revised at 1 of 7 sitesv7
  36. Study sites: 6 to 7v6
  37. Study sites: 5 to 6v5
  38. Study sites: 3 to 5v4
  39. Study sites: 1 to 3v3
  40. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2022 to Jan 27, 2022
    v2
  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 Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).
Trial Details
NCT Number NCT05208047
Lead Sponsor Cogent Biosciences, Inc.
Conditions
(from sponsor)		 Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
Related terms Gastrointestinal Stromal Tumors, Neoplasm Metastasis
Enrollment 482 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov