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Evaluating Onureg in Patients with Liver Impairment and Myeloid Malignancies

A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Adult Subjects With Myeloid Malignancies

Phase 1 Interventional Bristol-Myers Squibb · NCT05209295

This study tests how well the cancer drug Onureg works and its safety for people with blood cancers who also have liver problems.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment32 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsChemotherapy
Locations22 sites (Iowa City, Iowa and 21 other locations)
Trial IDNCT05209295 on ClinicalTrials.gov

What this trial studies

This study evaluates how moderate or severe liver impairment affects the drug levels and safety of oral azacitidine (Onureg) in patients with myeloid malignancies. Participants will include those diagnosed with specific types of blood cancers and varying degrees of liver function. The study aims to determine the tolerability of the medication in this unique patient population, which may have different responses due to their liver condition.

Who should consider this trial

Good fit: Ideal candidates are individuals with myeloid malignancies and moderate to severe hepatic impairment.

Not a fit: Patients with stable liver function or those who have received recent chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safe treatment options for patients with liver impairment who have myeloid malignancies.

How similar studies have performed: While studies on azacitidine exist, this specific evaluation in patients with hepatic impairment is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

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 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 this trial is running

Iowa City, Iowa and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatic InsufficiencyNeoplasmsCC-486AzacitidineHepatic ImpairmentOnuregMyeloid Malignancies
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.