A Phase I, Open-label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.
研究概览
简要总结
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies.
To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.
Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of hepatic function status on panobinostat PK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- •Patient has normal or abnormal hepatic organ function
- •Patient has provided written informed consent prior to any screening procedures
排除标准
- •Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
- •Patient received prior treatment with DAC inhibitors including panobinostat
- •Patient requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
- •Patient has encephalopathy
- •Patient has ascites requiring intervention
- •Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
HDACi
干预措施: LBH589 (Drug)
结局指标
主要结局
To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.
时间窗: first 7 days
次要结局
- To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat(entire duration of study)
- To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function(first 7 days)
- To explore anti-tumor activity associated with panobinostat.(best overall response)