A Phase I, Open-label, Multi-center Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Varying Degrees of Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- To assess the effect of varying degrees of renal function as defined by creatinine clearance), 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 renal 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 renal 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 requiring dialysis
- •Patient requiring diuretics unless patient is taking potassium sparring diuretics
- •Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
- •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
LBH589
干预措施: panobinostat (LBH589) (Drug)
结局指标
主要结局
To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.
时间窗: First 7 days
次要结局
- To assess the effect of varying degrees of renal function on the safety of panobinostat(Entire duration of study)
- To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.(7 days)
- To explore anti-tumor activity associated with panobinostat.(6 months (6 cycles))