Hepatic Insufficiency, Neoplasms
Conditions
Keywords
CC-486, Azacitidine, Hepatic Impairment, Onureg, Myeloid Malignancies
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.
Interventions
DRUGOnureg
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 9 Months |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 9 Months |
| Incidence of adverse events | Up to 9 Months |
| Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Liver Function tests | Up to 9 Months |
| Number of clinically significant changes in physical examinations | Up to 9 Months |
| Number of participants with a recording of concomitant medications | Up to 9 Months |
| Number of participants with a recording of concomitant procedures | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | 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 |
Countries
Argentina, Colombia, Germany, Spain, United States
Outcome results
None listed