A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

Last updated: November 4, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Liver Disease

Liver Failure

Treatment

Onureg

Clinical Study ID

NCT05209295
CA055-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acutepromyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negativemyeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasmsoverlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blasticplasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification

  • Life expectancy of ≥ 3 months

  • Stable renal function without dialysis for at least 2 months prior toinvestigational product administration

  • Has moderate or severe hepatic impairment as defined by National Cancer InstituteOrgan Dysfunction Working Group criteria

Exclusion

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer,prior to the first day of investigational product administration

  • Persistent, clinically significant non-hematologic toxicities from prior therapieswhich have not recovered to < Grade 2

  • Any condition including the presence of laboratory abnormalities, which places theparticipant at unacceptable risk if he/she were to participate in the study

  • History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastricbypass, upper bowel removal, or any other gastrointestinal disorder or defect thatwould interfere with the absorption of the investigational product and/or predisposethe participant to an increased risk of gastrointestinal toxicity

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Onureg
Phase: 1
Study Start date:
July 12, 2024
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Hospital Universitario Austral

    Pilar, Buenos Aires 1629
    Argentina

    Active - Recruiting

  • Local Institution - 0011

    Pilar, Buenos Aires 1629
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

    Active - Recruiting

  • Local Institution - 0010

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

    Site Not Available

  • Hospital Aleman

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
    Argentina

    Active - Recruiting

  • Local Institution - 0014

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
    Argentina

    Site Not Available

  • Clínica Zabala

    Buenos Aires, 1426
    Argentina

    Active - Recruiting

  • Local Institution - 0012

    Buenos Aires, 1426
    Argentina

    Site Not Available

  • Instituto Nacional De Cancerologia

    Bogota, Cundinamarca 111151
    Colombia

    Active - Recruiting

  • Local Institution - 0084

    Bogota, Cundinamarca 111151
    Colombia

    Site Not Available

  • Fundacion Ctic Centro de Tratamiento E Investigacion Sobre Cancer Luis Carlos Sarmiento Angulo

    Bogotá, Distrito Capital De Bogotá 110131
    Colombia

    Active - Recruiting

  • Local Institution - 0085

    Bogotá, Distrito Capital De Bogotá 110131
    Colombia

    Site Not Available

  • Local Institution - 0086

    Floridablanca, Santander 681004
    Colombia

    Site Not Available

  • Fundación Cardiovascular de Colombia

    Piedecuesta, Santander 681017
    Colombia

    Active - Recruiting

  • Local Institution - 0086

    Piedecuesta, Santander 681017
    Colombia

    Site Not Available

  • Klinikum Augsburg

    Augsburg, Bayern 86156
    Germany

    Active - Recruiting

  • Local Institution - 0076

    Augsburg, Bayern 86156
    Germany

    Site Not Available

  • Local Institution - 0075

    Halle, Sachsen-Anhalt 06120
    Germany

    Active - Recruiting

  • Local Institution - 0074

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Local Institution - 9000

    Thessaloniki, 54622
    Greece

    Site Not Available

  • Local Institution - 0018

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0017

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Local Institution - 0015

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Local Institution - 0078

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Local Institution - 0083

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Tulane Cancer Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Local Institution - 0068

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Local Institution

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Local Institution - 0007

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Local Institution

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Local Institution - 9003

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

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