A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Study acronym: DENALI
StatusRecruiting
PhasePhase 2
Started

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Record History

The 50 most recent of 61 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 92 → 86 locations
    • Eligibility criteria expanded, about 15 words
    • Study description revised
  2. Study sites: 91 to 92v60
  3. Study sites: 90 to 91v59
  4. Enrollment increased: 170 → 310 participants
    • Trial arms changed: 4 → 5
    • Eligibility criteria expanded, about 60 words
    • Site contacts updated at 76 of 90 sites
    v58
  5. Study sites: 89 to 90v57
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 88 to 89v56
  2. Study sites: 87 to 88v55
  3. Study sites: 86 to 87v54
  4. Study sites: 82 to 86v53
  5. Study sites: 70 to 82v52
  6. Study sites: 57 to 70v51
  7. Study sites: 50 to 57v50
  8. Study sites: 45 to 50v49
  9. Study sites: 42 to 45v48
  10. Study sites: 41 to 42v47
  11. Trial status: Active, Not Recruiting to Recruitingv46 Show 10 more changesShow less
    • Enrollment target: 102 to 170
    • Primary completion date: Apr 30, 2025 to Dec 1, 2026
    • Primary endpoints: 4 to 1
    • Study sites: 59 to 41
    • Study completion date: Oct 31, 2025 to Jun 30, 2027
    • Interventions: ZN-c3 (Drug) to azenosertib (Drug)
    • Eligibility criteria expanded, about 400 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 61 words
    • Study arms: 1 to 4
  12. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: 100 to 102
    v45
  13. Trial status: Recruiting to Suspended Sponsor's reason: Suspended due to partial clinical hold issued by FDA
    • Enrollment target: 90 to 100
    • Study sites: 64 to 59
    v44
  14. Site contacts updated at 1 of 64 sitesv43
  15. Study sites: 63 to 64v42
  16. Study sites: 62 to 63v41
  17. Site contacts updated at 2 of 62 sitesv40
  18. Study sites: 59 to 62v39
  19. Study sites: 57 to 59v38
  20. Study sites: 56 to 57v37
  21. Study sites: 54 to 56v36
  22. Study sites: 53 to 54v35
  23. Site contacts updated at 3 of 53 sitesv34
  24. Study sites: 52 to 53v33
  25. Site contacts updated at 3 of 52 sitesv32
  26. Study sites: 49 to 52v31
  27. Study sites: 44 to 49v30
  28. Study sites: 43 to 44v29
  29. Study sites: 33 to 43v28
  30. Study sites: 32 to 33
    • Eligibility criteria shortened, about 90 words
    v27
  31. Study sites: 31 to 32v26
  32. Study sites: 29 to 31v25
  33. Eligibility criteria shortened, about 3 wordsv24
  34. Site contacts updated at 1 of 29 sitesv23
  35. Site contacts updated at 21 of 29 sitesv22
  36. 2 versions Re-verified since Aug 16, 2023, no change to tracked fieldsv20-v21
  37. Study sites: 24 to 29
    • Study arms: 0 to 1
    v19
  38. Study sites: 23 to 24v18
  39. Study sites: 22 to 23v17
  40. Study sites: 21 to 22v16
  41. Study sites: 20 to 21v15
  42. Study sites: 19 to 20v14
  43. Study sites: 17 to 19v13
  44. Re-verified, no change to tracked fieldsv12
  • 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 multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
Trial Details
NCT Number NCT05128825
Lead Sponsor K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions
(from sponsor)		 High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Related terms Ovarian Neoplasms
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov