TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts
NCT03816319 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-05-18
Summary
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.
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
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo urine and blood sample collection
- PROCEDURE
-
Bone Marrow Aspiration
Undergo bone marrow aspiration
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
- PROCEDURE
-
Multigated Acquisition Scan
Undergo MUGA
- DRUG
-
UAE Inhibitor TAK-243
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Guillaume Richard-Carpentier · University Health Network Princess Margaret Cancer Center LAO
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-12
- Primary Completion
- 2026-10-24
- Completion
- 2026-10-24
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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