NCT00398840终止1 期
A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)6 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
研究概览
简要总结
This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly.
Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.
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
- •Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
- •A histologically or cytologically confirmed advanced solid tumor
- •≥ 18 years of age
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
- •Karnofsky performance status ≥ 70%
- •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation.
- •Females of childbearing potential must have a negative serum pregnancy test.
- •Laboratory results must meet study criteria.
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
- •Surgery within 4 weeks prior to first infusion
- •Known untreated brain metastases
- •Pregnant or breastfeeding
- •Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
- •Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
结局指标
主要结局
To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
次要结局
- To determine the pharmacokinetic profile of ARQ 171
- To assess the preliminary anti-tumor activity of ARQ 171
研究者
研究点 (6)
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