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A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv26
  2. Study sites revised (44)v25 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 212 to 420 Primary completion date: May 2026 to Apr 2030 · Primary endpoints revised (3) · Study sites: 45 to 44 · 6 morev24 Show 9 more changesShow less
    • Primary completion date: May 2026 to Apr 2030
    • Primary endpoints revised (3)
    • Study sites: 45 to 44
    • Completion date: May 2027 to Apr 2030
    • Interventions: Azacitidine (Drug), Cytarabine (Drug), Daunorubicin (Drug), Venetoclax (Drug), Ziftomenib (Drug) to Azacitidine (Drug), Cytarabine (Drug), Daunorubicin (Drug), Quizartinib (Drug), Venetoclax (Drug), Ziftomenib (Drug)
    • Eligibility criteria expanded, about 117 words
    • Secondary endpoints: 18 to 23
    • Study arms: 11 to 13
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 28 to 45v23
  5. Site contacts updated at 12 of 28 sitesv22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 27 to 28v21
  2. Study sites: 25 to 27v20
  3. Study sites: 24 to 25v19
  4. Study sites: 23 to 24v18
  5. Study sites: 22 to 23v17
  6. Study sites: 21 to 22v16
  7. Study sites: 17 to 21v15
  8. Study sites: 16 to 17v14
  9. Study sites: 15 to 16v13
  10. Study sites: 13 to 15v12
  11. Study sites: 12 to 13v11
  12. Study sites: 10 to 12v10
  13. Study sites: 9 to 10v9
  14. Study sites: 8 to 9v8
  15. Study sites: 7 to 8v7
  16. Study sites: 6 to 7v6
  17. Study sites: 5 to 6v5
  18. Study sites: 3 to 5v4
  19. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of May 2023 to Jul 18, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of May 2023 to Jul 18, 2023
  20. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
Trial Details
NCT Number NCT05735184
Lead Sponsor Kura Oncology, Inc.
Conditions Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation, KMT2Ar +2 more
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov