NCT05209295终止1 期
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 人开始时间: 2024年7月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 35
- 主要终点
- AUC0-∞: Estimation of AUC calculated from time zero to infinity
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Experimental
干预措施: Onureg (Drug)
Group 2
Experimental
干预措施: Onureg (Drug)
Group 3
Other
Control - participants with normal hepatic function
干预措施: Onureg (Drug)
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)
研究者
研究点 (35)
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