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(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 36 words
    • Site details revised at 4 of 42 sites
  2. Site details revised at 3 of 42 sitesv28
  3. Site details revised at 2 of 42 sitesv27
  4. Primary completion date changed from estimate of Sep 2025 to Sep 19, 2025
    • Study completion date: Jul 2026 to Jul 2027
    • Site details revised at 1 of 42 sites
    v26
  5. Site details revised at 3 of 42 sitesv25
Show 23 earlier versionsHide 23 earlier versions
  1. Primary completion date: Jul 2025 to Sep 2025
    • Site details revised at 20 of 42 sites
    v24
  2. Study sites: 40 to 42v23
  3. Study sites: 39 to 40
    • Primary completion date: Jan 2025 to Jul 2025
    • Study completion date: Sep 2025 to Jul 2026
    • Secondary endpoints: 15 to 11
    v22
  4. Study sites: 38 to 39v21
  5. Study sites: 35 to 38v20
  6. Enrollment target: 120 to 140
    • Study sites: 33 to 35
    • Eligibility criteria expanded, about 199 words
    • Secondary endpoints reordered
    v19
  7. Study sites: 29 to 33v18
  8. Study sites: 27 to 29v17
  9. Study sites: 22 to 27v16
  10. Study sites: 21 to 22v15
  11. Primary endpoints revised (2)v14 Show 6 more changesShow less
    • Enrollment target: 140 to 120
    • Study sites: 20 to 21
    • Interventions: CGT9486 tablets (Drug) to bezuclastinib (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (15)
    • Study title revised
  12. Study sites: 14 to 20
    • Secondary endpoints revised (15)
    v13
  13. Study sites: 13 to 14v12
  14. Study sites: 11 to 13v11
  15. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (15)
    v10
  16. Study sites: 10 to 11v9
  17. Study sites: 9 to 10v8
  18. Study sites: 8 to 9v7
  19. Start date changed from estimate of Oct 2021 to Nov 9, 2021v6
  20. Study sites: 6 to 8v5
  21. Study sites: 5 to 6v4
  22. Study sites: 4 to 5
    • Start date: Sep 2021 to Oct 2021
    v3
  23. Study sites: 1 to 4
    • Start date: Aug 2021 to Sep 2021
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Trial Details
NCT Number NCT04996875
Lead Sponsor Cogent Biosciences, Inc.
Conditions
(from sponsor)		 Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
Related terms Hematologic Diseases, Hematologic Neoplasms, Hypersensitivity, Immune Complex Diseases, Immune System Diseases, Leukemia, Leukemia, Mast-Cell, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Mastocytosis, Mastocytosis, Systemic, Myeloproliferative Disorders, Neoplasms, Neoplasms by Site, Neoplasms, Connective Tissue, Skin Diseases, Soft Tissue Neoplasms, Urticaria Pigmentosa
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov