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

NCT05209295 | Terminated Phase 1 FDA Drug

• 1 other identifier: CA055-001
• Study Type: interventional
• Target: 2
• Locations: 5 countries
• Sites: 18

Brief Summary

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

Neoplasms; Hepatic Insufficiency

Keywords

CC-486; Azacitidine; Hepatic Impairment; Onureg; Myeloid Malignancies

Outcome Measures

Primary Outcomes (3)

• AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point

  Day 1

• AUC0-∞: Estimation of AUC calculated from time zero to infinity

  Day 1

• Cmax: Observed maximum concentration

  Day 1

Secondary Outcomes (15)

• Incidence of adverse events

  Up to 9 Months

• Incidence of serious adverse events

  Up to 9 Months

• Number of participants with clinically significant changes in electrocardiogram parameters

  Up to 9 Months

• Incidence of clinically significant changes in vital signs: Body temperature

  Up to 9 Months

• Incidence of clinically significant changes in vital signs: Respiratory rate

  Up to 9 Months

Study Arms (3)

Group 1

EXPERIMENTAL

Drug: Onureg

Group 2

EXPERIMENTAL

Drug: Onureg

Group 3

OTHER

Control - participants with normal hepatic function

Drug: Onureg

Interventions

Onureg DRUG

Specified dose on specified days

Also known as: CC-486, Oral Azacitidine

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (18)

Local Institution - 0083

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0069

Detroit, Michigan, 48202, United States

Location

Local Institution

Cleveland, Ohio, 44106, United States

Location

Local Institution - 9003

Charlottesville, Virginia, 22903, United States

Location

Local Institution - 0011

Pilar, Buenos Aires, 1629, Argentina

Location

Local Institution - 0010

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Local Institution - 0014

Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

Location

Local Institution - 0012

Buenos Aires, 1426, Argentina

Location

Local Institution - 0085

Bogotá, Bogota D.C., 110131, Colombia

Location

Local Institution - 0084

Bogota, Cundinamarca, 111151, Colombia

Location

Local Institution - 0086

Piedecuesta, Santander Department, 681017, Colombia

Location

Local Institution - 0076

Augsburg, Bavaria, 86156, Germany

Location

Local Institution - 0075

Halle, Saxony-Anhalt, 06120, Germany

Location

Local Institution - 0074

Hamburg, 20246, Germany

Location

Local Institution - 0018

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0017

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0015

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 0078

Salamanca, 37007, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Hepatic Insufficiency; Neoplasms

Interventions

cc-486; Azacitidine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: July 12, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

AR (4); ES (4); DE (3); US (4); CO (3)