NCT01336582已完成1 期
Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC
研究概览
简要总结
Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.
详细描述
Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subjects who aged 18 years or older.
- •Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
- •Subjects who have histologically or cytologically confirmed advanced solid tumor.
- •Subjects who are a suitable candidate for single agent docetaxel therapy for their advanced solid tumors that have failed to standard therapy.
- •Subjects who have fully recovered from reversible toxic effects of prior therapy. The prior chemotherapy, immunotherapy, hormone therapy, surgery, and/or radiotherapy should be completed at least 21 days before the first administration of investigational product.
排除标准
- •Subjects who have had a major surgery other than tumor ablation within 2 weeks prior to the screening/baseline visit.
- •Subjects who have a history of metastasis or currently have a metastasis to the central nervous system (CNS).
- •Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 2 based on NCI CTCAE V3.0.
研究组 & 干预措施
docetaxel
Experimental
干预措施: taxotere (Drug)
Taxotere
Active Comparator
Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)
干预措施: taxotere (Drug)
结局指标
主要结局
Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC
时间窗: 3 months
次要结局
- Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere(3 months)
- Pharmacokinetics of the CL of SYP-0704A and Taxotere(3 months)
- Pharmacokinetics of the Vdss of SYP-0704A and Taxotere(3 months)
- Number of paticipants with Adverse Events(3months)
研究者
研究点 (1)
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