TERMINATED

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

Conditions

Hepatic Insufficiency Neoplasms CC-486 Azacitidine Hepatic Impairment Onureg Myeloid Malignancies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-12

Study Completion:2025-04-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05209295

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0083

Iowa City, Iowa, 52242

United States

Local Institution - 0069

Detroit, Michigan, 48202

United States

Local Institution

Cleveland, Ohio, 44106

United States

Local Institution - 9003

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12

Study Completion Date2025-04-20

Study Record Updates

Study Start Date2024-07-12

Study Completion Date2025-04-20

Terms related to this study

Keywords Provided by Researchers

CC-486
Azacitidine
Hepatic Impairment
Onureg
Myeloid Malignancies

Additional Relevant MeSH Terms

Hepatic Insufficiency
Neoplasms