MedDataX Logo

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

NCT ID: NCT05209295

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2025-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)

NCT01465412

Chronic Hepatic Impairment
COMPLETED PHASE1

Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject

NCT05684653

Hepatic Impairment
UNKNOWN PHASE1

Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects

NCT03824678

Hepatic Impairment Healthy Volunteers
COMPLETED PHASE1

Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

NCT01512693

Hepatic Insufficiency
COMPLETED PHASE1

PK Study in Subjects With Severe Hepatic Impairment

NCT03664544

Severe Hepatic Impairment Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Insufficiency Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Group Type EXPERIMENTAL

Onureg

Intervention Type DRUG

Specified dose on specified days

Group 2

Group Type EXPERIMENTAL

Onureg

Intervention Type DRUG

Specified dose on specified days

Group 3

Control - participants with normal hepatic function

Group Type OTHER

Onureg

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Onureg

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CC-486, Oral Azacitidine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0083

Iowa City, Iowa, United States

Site Status

Local Institution - 0069

Detroit, Michigan, United States

Site Status

Local Institution

Cleveland, Ohio, United States

Site Status

Local Institution - 9003

Charlottesville, Virginia, United States

Site Status

Local Institution - 0011

Pilar, Buenos Aires, Argentina

Site Status

Local Institution - 0010

ABB, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0014

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0012

Buenos Aires, , Argentina

Site Status

Local Institution - 0085

Bogotá, Bogota D.C., Colombia

Site Status

Local Institution - 0084

Bogota, Cundinamarca, Colombia

Site Status

Local Institution - 0086

Piedecuesta, Santander Department, Colombia

Site Status

Local Institution - 0076

Augsburg, Bavaria, Germany

Site Status

Local Institution - 0075

Halle, Saxony-Anhalt, Germany

Site Status

Local Institution - 0074

Hamburg, , Germany

Site Status

Local Institution - 0018

Badalona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0017

Barcelona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0015

Pamplona, Navarre, Spain

Site Status

Local Institution - 0078

Salamanca, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Colombia Germany Spain

Related Links

Access external resources that provide additional context or updates about the study.

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA055-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
NCT03289234 COMPLETED PHASE1
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
NCT00692341 COMPLETED PHASE1
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
NCT04639115 COMPLETED PHASE1
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
NCT04831944 COMPLETED PHASE1
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
NCT04482270 COMPLETED PHASE1
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
NCT07282093 RECRUITING PHASE1
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
NCT02474537 COMPLETED PHASE1
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
NCT04056468 COMPLETED PHASE1
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
NCT04960124 COMPLETED PHASE1
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
NCT03290443 COMPLETED PHASE1
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
NCT03902002 COMPLETED PHASE1
Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers
NCT00128947 COMPLETED PHASE1
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
NCT04604496 COMPLETED PHASE1
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
NCT04867941 COMPLETED PHASE1
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
NCT04476849 COMPLETED PHASE1
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects
NCT01456663 COMPLETED PHASE1
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
NCT04831996 COMPLETED PHASE1
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
NCT06442436 RECRUITING PHASE1
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
NCT03295266 TERMINATED PHASE1
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
NCT01790607 COMPLETED PHASE1
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
NCT03535662 COMPLETED PHASE1
MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
NCT02050815 TERMINATED PHASE1
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
NCT05706623 COMPLETED PHASE1
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone
NCT06388616 COMPLETED PHASE1
A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers
NCT01380223 COMPLETED PHASE1