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NCT03816319 · ClinicalTrials.gov record · last posted 2026-08-27

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

StatusSuspended
PhasePhase 1
Started2025-03-12
View on ClinicalTrials.gov ↗
Why the trial stopped
Unacceptable Toxicity
from the ClinicalTrials.gov record
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.

Protocol amendment history 5 changes detected by DataLookout

2026-08-28
Recruitment suspended
2026-08-28
Recruitment suspended: Unacceptable Toxicity
2026-07-28
Recruitment resumed after suspension
2026-05-16
Recruitment suspended
2026-05-16
Reason stopped changed: — → Other - Pending amendment addressing dose escalation plan.
Trial Details
NCT Number NCT03816319
Lead Sponsor National Cancer Institute (NCI)
Conditions 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
Enrollment 42 participants
Start Date 2025-03-12
Primary Completion 2026-10-24 (estimated)
Study Completion 2026-10-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-27