OncoMatch/Clinical Trials/NCT03816319
TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts
Is NCT03816319 recruiting? Yes, currently enrolling (Aug 2026). This Phase 1 trial studies UAE Inhibitor TAK-243 for myelodysplastic syndrome with excess blasts.
Treatment: UAE Inhibitor TAK-243 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — relapsed or refractory AML or MDS-IB
Patients must have relapsed or refractory disease after receiving at least one prior line of therapy
Lab requirements
Kidney function
Serum creatinine < 176 mcmol/L (2 mg/dL) OR creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
Serum bilirubin <= 1.5 × institutional ULN (Gilbert's syndrome allowed); AST/ALT <= 3 × institutional ULN
Cardiac function
Documented normal cardiac function (>= 50%) by echocardiogram or MUGA scan
Serum bilirubin <= 1.5 × institutional ULN (Gilbert's syndrome allowed); AST/ALT <= 3 × institutional ULN; Serum creatinine < 176 mcmol/L (2 mg/dL) OR creatinine clearance ≥ 60 mL/min (Cockcroft-Gault); Documented normal cardiac function (>= 50%) by echocardiogram or MUGA scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Northwestern University · Chicago, Illinois
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- VCU Massey Comprehensive Cancer Center · Richmond, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03816319 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify