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

Description

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.

Conditions

Hepatic Insufficiency, Neoplasms

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Study Overview

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Study Details

Study 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.

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

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

Condition
Hepatic Insufficiency
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

New Orleans

Tulane Cancer Center, New Orleans, Louisiana, United States, 70112

Worcester

Local Institution - 0068, Worcester, Massachusetts, United States, 01655

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Port Jefferson Station

Local Institution - 0007, Port Jefferson Station, New York, United States, 11776

Cleveland

Local Institution, Cleveland, Ohio, United States, 44106

Charlottesville

University of Virginia Cancer Center, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-06-01