NCT00248404已完成1 期
A Phase I/II Study of NB1011 Administered Intravenously by Continuous Infusion in an Every Second Week Regimen With Open-label Continuation in Cancers That Overexpress the Enzyme Thymidylate Synthase
Kiadis Pharma6 个研究点 分布在 2 个国家目标入组 155 人开始时间: 2005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
- 155
- 试验地点
- 6
- 主要终点
- Safety/tolerability of NB1011 infusions
研究概览
简要总结
The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.
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
- •Advanced, recurrent, or metastatic solid tumors
- •TS overexpression (> 4 by reverse transcription polymerase chain reaction [RT-PCR]) in archival and fresh samples
- •Suitable for experimental monotherapy
- •Measurable disease
排除标准
- •Tumors that cannot be biopsied or with low level of TS expression
- •Requirement for concomitant anticancer therapy
- •Treatment with another investigational product within 30 days of study entry
- •Pregnant or lactating women
- •Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
- •HIV infection
- •Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis
结局指标
主要结局
Safety/tolerability of NB1011 infusions
Determination of maximum tolerated dose (MTD)
次要结局
- Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Pharmacokinetics of NB1011 and its metabolite
- Assessment of TS overexpression
研究者
研究点 (6)
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