RecruitingPhase 1Phase 2NCT03850574

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Sponsor

Aptose Biosciences Inc.

Enrollment

240 participants

Start Date

Mar 11, 2019

Study Type

INTERVENTIONAL

Conditions

Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome With Excess Blasts-2 Leukemia, Myeloid, Acute Refractory AML Relapsed Adult AML

Summary

The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug in patients with blood cancers including certain types of leukemia (AML), a pre-leukemia condition (MDS with more than 10% blasts in the bone marrow), or a related blood disorder (CMML), whose cancer has not responded to or has come back after previous treatments. **You may be eligible if...** - You have been diagnosed with AML (acute myeloid leukemia), high-grade MDS (myelodysplastic syndrome with at least 10% blasts), or CMML (chronic myelomonocytic leukemia) - Your disease relapsed after treatment or did not respond to at least one prior treatment - You are in reasonably good health (ECOG performance status of 2 or less) - Enough time has passed since your last treatment (at least 2 weeks for most chemotherapy, or 5 half-lives for targeted drugs) **You may NOT be eligible if...** - You have not had prior treatment for your blood cancer - You have significant organ damage or other serious medical conditions - You have not waited long enough after your last treatment before joining this study - You have active, uncontrolled infections 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

DRUGTuspetinib

Daily (QD), continuous dosing

DRUGVenetoclax Oral Tablet

Venetoclax will be given to study participants in the Part C tuspetinib plus venetoclax combination treatment group either in 50 mg or 100 mg tablets

DRUGAzacitidine for Intravenous Infusion

Azacitidine will be given to study participants in Part D as intravenous infusion at a dose of 75 mg/m\^2

Locations(34)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of California Irvine

Irvine, California, United States

UCSD Moores Cancer Center

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

University of California, Davis

Sacramento, California, United States

Yale University

New Haven, Connecticut, United States

University of Miami - Miller School of Medicine

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic - Taussig Cancer Center

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

MD Anderson Cancer Center

Huston, Texas, United States

Border Medical Oncology

Albury, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Townsville University Hospital

Townsville, Queensland, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Auckland City Hospital

Grafton, Auckland, New Zealand

Seoul National University Hospital

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Pusan National University Hospital

Pusan, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

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NCT03850574

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