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Trial ID CA055-001  |   NCT05209295

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 17
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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
    1. Life expectancy of ≥ 3 months
      1. Stable renal function without dialysis for at least 2 months prior to investigational product administration
        1. Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration
            1. Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2
              1. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
                1. 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
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Group 1

                  ASSIGNED INTERVENTION
                  • Drug: Onureg

                  Study Arms

                  Experimental: Group 2

                  ASSIGNED INTERVENTION
                  • Drug: Onureg

                  Study Arms

                  Other: Group 3

                  ASSIGNED INTERVENTION
                  • Drug: Onureg
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