Actively Recruiting
TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
42
Participants Needed
5
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML or MDS with increased blasts according to 2022 WHO criteria
- Relapsed or refractory disease after at least one prior therapy
- For AML: relapsed or refractory with 5% bone marrow blasts after intensive chemotherapy or venetoclax-based regimen
- For MDS: relapsed or refractory with 5% bone marrow blasts after hypomethylating agent therapy or intensive chemotherapy
- Recovery from prior therapy effects, with no investigational therapy within 2 weeks or standard chemotherapy within 1 week
- Age 18 years or older
- ECOG performance status 2 (Karnofsky 50%)
- Serum bilirubin 1.5 times institutional upper limit of normal
- AST/ALT 3 times institutional upper limit of normal
- Serum creatinine < 176 mcmol/L or creatinine clearance > 60 mL/min
- Normal cardiac function (ejection fraction 50%) by ECHO or MUGA
- HIV patients on effective therapy with undetectable viral load within 6 months
- Controlled hepatitis B or cured hepatitis C infection
- Female patients must be postmenopausal, surgically sterile, or use effective contraception
- Male patients must use effective contraception or practice true abstinence
- Ability and willingness to sign informed consent
- Minimum life expectancy of 1 month
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or AML with t(15;17) translocation
- Unrecovered adverse events from prior therapy except certain blood-related toxicities and grade 2 neuropathy
- Other active malignancies requiring treatment
- Receiving other investigational agents
- Allergic reactions to compounds similar to TAK-243
- Use of certain drug interactions such as OATP, BCRP inhibitors, or CYP3A4/5 modifiers
- Active uncontrolled infections or severe infectious diseases
- Active graft-versus-host disease or ongoing immunosuppressive treatment after stem cell transplant
- Medical conditions compromising safety or study participation
- Pregnant or breastfeeding women
- Major surgery within 14 days before first dose or scheduled surgery during study
- Uncontrolled bleeding or coagulopathy
- Known hepatic cirrhosis
- Active cardiopulmonary disease including recent unstable angina, recent myocardial infarction, severe heart failure, cardiomyopathy, or pulmonary hypertension
- Active central nervous system involvement
- Significant arrhythmias or recent serious atrial fibrillation/flutter
- Uncontrolled high blood pressure
- Prolonged QTc interval 480 msec
- Severe chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis
- Intent to donate eggs or sperm during study or 4 months after last dose
- History of certain inflammatory or autoinflammatory diseases including VEXAS syndrome or giant cell arteritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
5
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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