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Proteasome Inhibitor

TAK-243 for Leukemia

Phase 1

Recruiting

Led By Dawn C Maze

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of AML or MDS with increased blasts according to the 2022 WHO criteria

Patients must have relapsed or refractory disease after receiving at least one prior line of therapy

Must not have

Presence of active severe infections or diseases

Active cardiopulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TAK-243 to see what dose is safe and what side effects it may cause in patients with certain types of blood cancer that has come back or is not

Who is the study for?

This trial is for adults with acute myeloid leukemia or myelodysplastic syndromes that have relapsed or are not responding to treatment. Participants must meet specific health criteria, including a certain performance status and liver function. They should not have had recent chemotherapy or investigational therapy and cannot be allergic to the study drug TAK-243.

What is being tested?

The trial is testing TAK-243, which may inhibit cancer cell growth by blocking enzymes needed for cell growth. It involves procedures like bone marrow aspiration/biopsy and heart function tests to determine the best dose of TAK-243 and its side effects in patients.

What are the potential side effects?

Potential side effects of TAK-243 include reactions related to inhibiting enzymes necessary for cancer cell growth, which could affect normal cells as well. Specific side effects will be monitored through various medical assessments during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with AML or MDS with a high number of immature blood cells.

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My condition worsened or didn't improve after at least one treatment.

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My MDS has returned or didn't respond to treatment, with more than 5% bone marrow blasts.

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I am 18 years old or older.

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My kidney function is normal based on my creatinine levels.

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My heart function is normal.

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I am HIV positive, on treatment, and my viral load is undetectable.

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I had hepatitis C but have been treated and cured.

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My chronic hepatitis B virus infection is under control with no detectable virus.

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I am using effective birth control methods.

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I can take care of myself but might not be able to do heavy physical work.

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My AML has returned or didn't respond to treatment, with more than 5% of my bone marrow cells being cancerous.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe infections or diseases.

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I have a heart or lung condition that is currently causing symptoms.

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My cancer has spread to my brain.

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I have a severe lung condition.

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I am currently taking specific inhibitor medications.

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I am currently receiving treatment for another cancer.

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I have a specific type of leukemia.

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I am currently experiencing GVHD or taking immunosuppressants after a stem cell transplant.

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I do not have any uncontrolled bleeding disorders.

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I have a serious irregular heartbeat.

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I have a history of skin or autoinflammatory diseases.

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I have side effects from past treatments that are not severe.

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I have been diagnosed with liver cirrhosis.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase II dose (RP2D)

Secondary study objectives

Demonstration of UBA1-TAK-243 engagement

Incidence of adverse events

Incidence of dose-limiting toxicities (DLTs)

+22 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TAK-243)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Multigated Acquisition Scan

2015

Completed Phase 3

~270