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

Bristol-Myers Squibb35 个研究点分布在 5 个国家目标入组 2 人2024年7月12日

适应症Hepatic Insufficiency Neoplasms

干预措施Onureg

概览

阶段: 1 期
干预措施: Onureg
疾病 / 适应症: Hepatic Insufficiency
发起方: Bristol-Myers Squibb
入组人数: 2
试验地点: 35
主要终点: AUC0-∞: Estimation of AUC calculated from time zero to infinity
状态: 终止
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年7月12日

结束日期

2025年4月20日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bristol-Myers Squibb

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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

研究组 & 干预措施

Group 1

干预措施: Onureg

Group 2

干预措施: Onureg

Group 3

Control - participants with normal hepatic function

干预措施: Onureg

结局指标

主要结局

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

时间窗: Day 1

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

时间窗: Day 1

Cmax: Observed maximum concentration

时间窗: Day 1

次要结局

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: 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 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: 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 vital signs: Respiratory rate(Up to 9 Months)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 9 Months)
Number of clinically significant changes in physical examinations(Up to 9 Months)