NCT00612703已完成1 期
A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Erlotinib 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)4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年2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
- 32
- 试验地点
- 4
- 主要终点
- To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors
研究概览
简要总结
To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors
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 according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- •A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
- •≥ 18 years of age
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
- •Major surgery within 4 weeks prior to first dose
- •Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
- •Pregnant or breastfeeding
- •Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)
结局指标
主要结局
To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors
时间窗: No time frame
次要结局
- To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors(No time frame)
- To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors(No time frame)
研究者
研究点 (4)
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