NCT02597465撤回3 期
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
研究概览
简要总结
An open label study to determine the efficacy and safety of SPARC1507
详细描述
Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Evidence of advanced/metastatic biliary tract cancer
- •Male or female ≥ 18 years old
- •Participants must have measurable disease according to RECIST
- •ECOG performance status ≤ 1
排除标准
- •Known hypersensitivity to trial treatments, or their excipients
- •Prior history of treatment with any taxane therapy
- •Cardiovascular disorders as per Investigator's discretion
- •The subject has received radiation therapy
研究组 & 干预措施
SPARC1507
Experimental
SPARC1507
干预措施: SPARC1507 (Drug)
Chemotherapy
Experimental
Chemotherapy
干预措施: Reference1507 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
时间窗: 3 years and 6 months
次要结局
- Overall survival in subjects treated with SPARC1507 versus Investigators choice(3 years and 6 months)
- Overall response rate in subjects treated with PICN versus Investigators choice(3 years and 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 years and 6 months)
研究者
研究点 (1)
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