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
- Registration Number
- NCT05209295
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 Onureg Control - participants with normal hepatic function Group 2 Onureg - Group 1 Onureg -
- Primary Outcome Measures
Name Time Method AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point Day 1 Cmax: Observed maximum concentration Day 1 AUC0-∞: Estimation of AUC calculated from time zero to infinity Day 1
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 9 Months Incidence of clinically significant changes in clinical laboratory results: Liver Function tests Up to 9 Months Number of participants with a recording of concomitant medications 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: 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 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 Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status Up to 9 Months Incidence of adverse events Up to 9 Months Incidence of clinically significant changes in vital signs: Respiratory rate Up to 9 Months Number of clinically significant changes in physical examinations Up to 9 Months
Trial Locations
- Locations (18)
Local Institution - 0083
🇺🇸Iowa City, Iowa, United States
Local Institution - 0069
🇺🇸Detroit, Michigan, United States
Local Institution - 9003
🇺🇸Charlottesville, Virginia, United States
Local Institution - 0011
🇦🇷Pilar, Buenos Aires, Argentina
Local Institution - 0010
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0014
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0012
🇦🇷Buenos Aires, Argentina
Local Institution - 0084
🇨🇴Bogota, Cundinamarca, Colombia
Local Institution - 0085
🇨🇴Bogotá, Distrito Capital De Bogotá, Colombia
Local Institution - 0086
🇨🇴Piedecuesta, Santander, Colombia
Scroll for more (8 remaining)Local Institution - 0083🇺🇸Iowa City, Iowa, United States