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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 - CA055-001

Updated: 6 February, 2024   |

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18+

    Age Range

  • 18


  • Recruiting

Treatment Options

Study Arms
Experimental: Group 1
Drug: Onureg
Experimental: Group 2
Drug: Onureg
Other: Group 3
Drug: Onureg

Key Eligibility 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

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