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
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Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
2actual
Sites
18
Countries
Argentina, Colombia, Germany +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Insufficient Enrollment
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-12 | actual | When the study began enrolling |
| Primary completion | 2025-04-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-20 | actual | The whole study's end, after follow-up |
| First posted | 2022-01-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hepatic Insufficiency
- Neoplasms
Intervention
- Drug: Onureg — also filed as CC-486, Oral Azacitidine
Primary outcomes
what the primary-completion date above is the date OFAUC0-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
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