NCT00289809已完成1 期
A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Phase II: Response rate (CR/PR or SD)
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response
详细描述
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.
Then, Phase II study started.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •* Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
- •* Age \>/=18 yrs
- •* PS \/=3 mos
- •* Minimum 4 wks from last radiotherapy
- •* Adequate medullary, liver, and renal functions
- •* Normal LVEF
- •* Written Informed Consent
排除标准
- •Pregnant or breast-feeding patients
- •Serious concomitant disease or not controlled infections
结局指标
主要结局
Phase II: Response rate (CR/PR or SD)
时间窗: Tumor assessment
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
时间窗: Definition of TDL
次要结局
- Phase II: time to progression, duration of response, overall survival(Tumor assessment, follow-up)
研究者
研究点 (2)
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