Hepatic InsufficiencyPhase 1NCT05209295
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
A Phase 1 study testing Onureg in people with Hepatic Insufficiency and Neoplasms, run by Bristol-Myers Squibb at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Insufficiency, Neoplasms
- What is being tested?
- Onureg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 12 Jul 2024to 20 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States4 sites
Local Institution - 9003
Charlottesville, Virginia, 22903
Local Institution
Cleveland, Ohio, 44106
Local Institution - 0069
Detroit, Michigan, 48202
Local Institution - 0083
Iowa City, Iowa, 52242
Argentina4 sites
Local Institution - 0010
ABB, Buenos Aires F.D., C1199ABB
Local Institution - 0014
Buenos Aires, Buenos Aires F.D., C1118AAT
Local Institution - 0012
Buenos Aires, 1426
Local Institution - 0011
Pilar, Buenos Aires, 1629
Spain4 sites
Local Institution - 0018
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0017
Barcelona, Barcelona [Barcelona], 08035
Local Institution - 0015
Pamplona, Navarre, 31008
Local Institution - 0078
Salamanca, 37007
Colombia3 sites
Local Institution - 0084
Bogota, Cundinamarca, 111151
Local Institution - 0085
Bogotá, Bogota D.C., 110131
Local Institution - 0086
Piedecuesta, Santander Department, 681017
Germany3 sites
Local Institution - 0076
Augsburg, Bavaria, 86156
Local Institution - 0075
Halle, Saxony-Anhalt, 06120
Local Institution - 0074
Hamburg, 20246
About this study
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
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
- Being tested
- Onureg
- Keywords
- CC-486, Azacitidine, Hepatic Impairment, Onureg, Myeloid Malignancies
- Medical subject headings
- Hepatic Insufficiency, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnuregDrug
Also called CC-486, Oral Azacitidine
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Onureg |
| Group 2 | Experimental | Not described Receives: Drug: Onureg |
| Group 3 | Other | Control - participants with normal hepatic function Receives: Drug: Onureg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
Measured: Day 1
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Measured: Day 1
Cmax: Observed maximum concentration
Measured: Day 1
Secondary outcomes (15)
Incidence of adverse events
Measured: Up to 9 Months
Incidence of serious adverse events
Measured: Up to 9 Months
Number of participants with clinically significant changes in electrocardiogram parameters
Measured: Up to 9 Months
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 9 Months
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 9 Months
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 9 Months
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 9 Months
Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status
Measured: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Liver Function tests
Measured: Up to 9 Months
Number of clinically significant changes in physical examinations
Measured: Up to 9 Months
Number of participants with a recording of concomitant medications
Measured: Up to 9 Months
Number of participants with a recording of concomitant procedures
Measured: Up to 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start12 Jul 2024
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209295
- Sponsor's protocol ID
- CA055-001
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05209295
- Acronym / sponsor ID
- CA055-001
- Conditions
- Hepatic Insufficiency, Neoplasms
- Keywords
- CC-486, Azacitidine, Hepatic Impairment, Onureg, Myeloid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Onureg |
| Group 2 | Experimental | Drug: Onureg |
| Group 3 | Other | Drug: OnuregControl - participants with normal hepatic function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnuregAlso: CC-486, Oral AzacitidineSpecified dose on specified days | Drug | Group 1, Group 2, Group 3 |
Primary outcome
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
Time frame: Day 1
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Time frame: Day 1
Cmax: Observed maximum concentration
Time frame: Day 1
15 secondary outcomes
Incidence of adverse events
Time frame: Up to 9 Months
Incidence of serious adverse events
Time frame: Up to 9 Months
Number of participants with clinically significant changes in electrocardiogram parameters
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 9 Months
Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Liver Function tests
Time frame: Up to 9 Months
Number of clinically significant changes in physical examinations
Time frame: Up to 9 Months
Number of participants with a recording of concomitant medications
Time frame: Up to 9 Months
Number of participants with a recording of concomitant procedures
Time frame: Up to 9 Months
Results and safety
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Onureg in people with Hepatic Insufficiency and Neoplasms, run by Bristol-Myers Squibb at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Argentina, Spain, Colombia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.