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First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 66 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 56 → 43 locationsv66 Show 1 more changeShow less
    • Trial sites reduced: 56 → 43 locations
  2. Site details revised at 11 of 56 sitesv65
  3. Site details revised at 1 of 56 sitesv64
  4. Site details revised at 12 of 56 sitesv63
  5. Site details revised at 2 of 56 sitesv62
Show 45 earlier versionsHide 45 earlier versions
  1. Primary endpoints: 4 to 17 Enrollment target: 199 to 263 · Study sites: 52 to 56 · Interventions: Ziftomenib (Drug) to Itraconazole (Drug), Midazolam (Drug), Ziftomenib (Drug) · 4 morev61 Show 7 more changesShow less
    • Enrollment target: 199 to 263
    • Study sites: 52 to 56
    • Interventions: Ziftomenib (Drug) to Itraconazole (Drug), Midazolam (Drug), Ziftomenib (Drug)
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: 10 to 26
    • Study description expanded, about 145 words
    • Study arms: 3 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Sep 30, 2024 to Oct 16, 2028 Completion date: Sep 30, 2025 to Oct 16, 2028v60 Show 1 more changeShow less
    • Completion date: Sep 30, 2025 to Oct 16, 2028
  3. Study sites: 50 to 52v59
  4. Study sites: 49 to 50v58
  5. Study sites: 45 to 49v57
  6. Study sites: 44 to 45v56
  7. Study sites: 43 to 44v55
  8. Study sites: 42 to 43v54
  9. Study sites revised (42)v53 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 40 to 42v52
  11. Study sites: 39 to 40v51
  12. Study sites: 38 to 39v50
  13. Site contacts updated at 15 of 38 sitesv49
  14. Site details revised at 1 of 38 sitesv48
  15. Study sites: 37 to 38v47
  16. Study sites: 35 to 37v46
  17. Study sites: 34 to 35v45
  18. Study sites: 33 to 34v44
  19. Study sites: 31 to 33v43
  20. Study sites: 30 to 31v42
  21. Site details revised at 1 of 30 sitesv41
  22. Study sites: 29 to 30v40
  23. Site details revised at 1 of 29 sitesv39
  24. Study sites: 28 to 29v38
  25. Study sites: 27 to 28v37
  26. Site details revised at 2 of 27 sitesv36
  27. Site details revised at 1 of 27 sitesv35
  28. Site details revised at 1 of 27 sitesv34
  29. Site details revised at 1 of 27 sitesv33
  30. Site details revised at 1 of 27 sitesv32
  31. Site details revised at 1 of 27 sitesv31
  32. Site details revised at 2 of 27 sitesv30
  33. Site details revised at 1 of 27 sitesv29
  34. Enrollment target: 60 to 199 Primary completion date: Jun 30, 2022 to Sep 30, 2024 · Primary endpoints: 3 to 4 · Study sites: 26 to 27 · 6 morev28 Show 9 more changesShow less
    • Primary completion date: Jun 30, 2022 to Sep 30, 2024
    • Primary endpoints: 3 to 4
    • Study sites: 26 to 27
    • Completion date: Dec 31, 2022 to Sep 30, 2025
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 20 words
    • Study title revised
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  35. Study sites: 25 to 26v27
  36. Enrollment target: 90 to 60 Primary endpoints revised (3) · Study sites: 21 to 25 · Primary completion date: Feb 1, 2022 to Jun 30, 2022 · 6 morev26 Show 9 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 21 to 25
    • Primary completion date: Feb 1, 2022 to Jun 30, 2022
    • Completion date: Aug 1, 2022 to Dec 31, 2022
    • Interventions: KO-539 (Drug) to Ziftomenib (Drug)
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 4 of 10 entries
    • Study description expanded, about 7 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  37. Site contacts updated at 1 of 21 sitesv25
  38. Study sites: 20 to 21v24
  39. Study sites: 18 to 20v23
  40. Re-verified, no change to tracked fieldsv22
  41. Site details revised at 3 of 18 sitesv21
  42. Study sites: 14 to 18v20
  43. Study sites: 13 to 14v19
  44. Study sites: 12 to 13v18
  45. Study sites: 11 to 12v17
  • 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.
In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The main study has completed enrollment. In Sub-studies 1 and 2, the effects of taking ziftomenib and other common drugs at the same time will be investigated in AML patients. In Sub-study 3, ziftomenib will be evaluated in patients with R/R acute lymphoblastic leukemia (ALL). In Sub-study 4, ziftomenib will be evaluated in patients with R/R AML with certain genetic mutations.
Trial Details
NCT Number NCT04067336
Lead Sponsor Kura Oncology, Inc.
Conditions Advanced Malignant Neoplasm, Acute Myeloid Leukemia, Mixed Lineage Leukemia, Mixed Lineage Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia
Enrollment 263 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov