RecruitingPhase 1NCT03816319

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

A Phase 1 Study of TAK-243 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts


Sponsor

National Cancer Institute (NCI)

Enrollment

42 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental drug called TAK-243 in patients with acute myeloid leukemia (AML — a fast-growing blood cancer) or myelodysplastic syndromes with increased abnormal cells (MDS-IB), whose cancer has come back or has not responded to previous treatments. **You may be eligible if...** - You have been diagnosed with AML or MDS with increased abnormal bone marrow cells - Your cancer has relapsed (come back) or is refractory (has not responded) to at least one prior treatment - For AML: you have tried at least two rounds of intensive chemotherapy, or at least two cycles of a gentler treatment regimen - For MDS: you have tried at least one prior treatment **You may NOT be eligible if...** - Your cancer has not been confirmed by a specialist laboratory - You have not yet tried any prior treatment - Your overall health or organ function is too poor to safely receive this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo urine and blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGUAE Inhibitor TAK-243

Given IV


Locations(5)

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03816319


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