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

Stopped early · Phase 1

Conditions studied: Hepatic Insufficiency, Neoplasms

In brief

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.

Key facts

Study ID

NCT05209295

Run by

Bristol-Myers Squibb

People needed

2

Starts

2024-07-12

Expected to finish

2025-04-20

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acute promyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negative myeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasms overlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blastic plasmacytoid 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 to investigational product administration
• Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria

You may not qualify if…

• 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 therapies which have not recovered to < Grade 2
• Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
• History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0083 — Iowa City, Iowa, United States
• Local Institution - 0069 — Detroit, Michigan, United States
• Local Institution — Cleveland, Ohio, United States
• Local Institution - 9003 — Charlottesville, Virginia, United States
• Local Institution - 0011 — Pilar, Buenos Aires, Argentina
• Local Institution - 0010 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0014 — Buenos Aires, Buenos Aires F.D., Argentina
• Local Institution - 0012 — Buenos Aires, Argentina
• Local Institution - 0085 — Bogotá, Bogota D.C., Colombia
• Local Institution - 0084 — Bogota, Cundinamarca, Colombia
• Local Institution - 0086 — Piedecuesta, Santander Department, Colombia
• Local Institution - 0076 — Augsburg, Bavaria, Germany
• Local Institution - 0075 — Halle, Saxony-Anhalt, Germany
• Local Institution - 0074 — Hamburg, Germany
• Local Institution - 0018 — Badalona, Barcelona [Barcelona], Spain
• Local Institution - 0017 — Barcelona, Barcelona [Barcelona], Spain
• Local Institution - 0015 — Pamplona, Navarre, Spain
• Local Institution - 0078 — Salamanca, Spain

Full record on ClinicalTrials.gov

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