TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 24, 2026 → Oct 24, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 118 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 24, 2026 to Oct 24, 2027
  2. Trial status changed: Suspended → Active, Not Recruiting
    • Eligibility criteria expanded, about 6 words
  3. Recruitment suspended Sponsor's reason: Unacceptable Toxicity
    • Site details revised at 5 of 5 sites
    v116
  4. Recruitment resumed after suspension
    • Site details revised at 5 of 5 sites
    v115
  5. Re-verified, no change to tracked fieldsv114
  6. Recruitment suspended Sponsor's reason: Other - Pending amendment addressing dose escalation plan.
    • Site details revised at 5 of 5 sites
    v113
  7. 9 versions Re-verified since Mar 31, 2026, no change to tracked fieldsv104-v112
  8. Site details revised at 1 of 5 sitesv103
  9. 15 versions Re-verified since Mar 6, 2026, no change to tracked fieldsv88-v102
  10. Study sites: 4 to 5v87
  11. 18 versions Re-verified since Feb 6, 2026, no change to tracked fieldsv69-v86
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Trial Details
NCT Number NCT03816319
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Myelodysplastic Syndrome With Excess Blasts, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome/Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia
Related terms Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov