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

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03816319
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo urine and blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • UAE Inhibitor TAK-243 — DRUG
    Given IV

Study Details

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.

Key Dates

First listed
Jan 25, 2019
Start date
Mar 12, 2025
Status verified
Jul 2026
Primary completion
Oct 24, 2026
Completion
Oct 24, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (TAK-243)
    Patients receive TAK-243 IV over 30 minutes on days 1, 4, 8, and 11 of each cycle. Cycles repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo urine sample collection, bone marrow aspiration and bone marrow biopsy, MUGA and ECHO during screening and on study, and blood sample collection throughout the trial.

Primary Outcome Measure

Recommended phase II dose (RP2D) [ Time Frame: At 21 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Site Public Contact
[email protected]
800-679-0775
Jeffrey E. Lancet (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Site Public Contact
[email protected]
312-695-1301
Himachandana Atluri (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
Shivani Handa (PRINCIPAL_INVESTIGATOR)
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298
Site Public Contact
[email protected]
804-628-6430
Keri R. Maher (PRINCIPAL_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FLNorthwestern University· Chicago, ILOhio State University Comprehensive Cancer Center· Columbus, OHVCU Massey Comprehensive Cancer Center· Richmond, VA

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