NCT00106613已完成2 期
An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
研究概览
简要总结
The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients must fulfill all of the following criteria to be eligible for study participation:
- •Age ≥ 18 years;
- •Histologically confirmed Renal Cell Carcinoma (RCC);
- •Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
- •Failure of prior cytokine therapy;
- •Documented progressive disease;
排除标准
- •Patients are ineligible for entry if any of the following criteria are met:
- •Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
- •History of serious ventricular arrhythmia
- •Corrected QT interval (QTc) ≥ 500 msec
- •Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
- •Previous extensive radiotherapy involving ≥ 30% of bone marrow
- •Coexistent second malignancy or history of prior malignancy within previous 5 years
研究组 & 干预措施
FK228 (romidepsin)
Experimental
13 mg/m2 of romidepsin
干预措施: FK228 (romidepsin) (Drug)
结局指标
主要结局
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
时间窗: Up to 6 months
次要结局
- Time to objective disease progression.(Up to 6 months)
- Number of Participants with Adverse Events(Up to 6 months)
- Steady state plasma concentrations(Up to 6 months)
- Rate of disease control, Complete Response, Partial Response, or Stable Disease(Up to 6 months)
- Change from screening assessment to the final study visit in Karnofsky performance status.(Up to 6 months)
研究者
研究点 (3)
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