NCT01305512已完成1 期
Pharmacokinetic, Safety and Tolerability Study of SPARC1028
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Determination of Maximum Tolerated Dose (MTD) during dose escalation
研究概览
简要总结
Evaluation of pharmacokinetic profile of SPARC1028
详细描述
This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.
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
- •Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
- •Age ≥18 years
- •ECOG Performance Status ≤
- •Estimated life expectancy of at least 12-weeks;
排除标准
- •Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
- •Known hypersensitivity to the study drugs
- •Treatment with any anti-cancer agents within 28 days of study entry
- •Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
研究组 & 干预措施
SPARC1028
Experimental
干预措施: SPARC1028 (Drug)
结局指标
主要结局
Determination of Maximum Tolerated Dose (MTD) during dose escalation
时间窗: One 21-day treatment cycle
MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
次要结局
- Establishing pharmacokinectic profile at each dose level for SPARC1028(One 21-day treatment cycle)
研究者
研究点 (1)
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