NCT01304303已完成1 期
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Determination of MTD
研究概览
简要总结
Phase I study of SPARC1023 alone and in combination with carboplatin
详细描述
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years
- •ECOG Performance Status ≤
- •Estimated life expectancy of at least 12-weeks;
- •Measurable disease as per RECIST guideline (Version 1.1);
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
SPARC1023 I
Experimental
干预措施: SPARC1023 I (Drug)
SPARC1023 II
Experimental
干预措施: SPARC1023 II (Drug)
结局指标
主要结局
Determination of MTD
时间窗: One 21-day treatment cycle
MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.
次要结局
- Establishing the pharmacokinetic profile(One 21-day treatment cycle)
研究者
研究点 (1)
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