NCT00310518已完成2 期
A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)10 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 10
研究概览
简要总结
The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Able to provide signed and dated informed consent prior to study-specific screening procedures.
- •Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic.
- •Measurable disease as defined by RECIST.
- •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 the last infusion of ARQ
- •Hemoglobin (Hgb) >= 10 g/dL.
- •Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1,500/mm3).
- •Platelet count >= 100 x 10^9/L (>= 100,000/mm3).
- •Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease.
- •Creatinine less than or equal to 1.5 x ULN.
排除标准
- •Received three or more prior anticancer chemotherapy regimens.
- •Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- •Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion.
- •Have symptomatic or untreated central nervous system (CNS) involvement.
- •Are pregnant or breastfeeding.
- •Previous exposure to ARQ 501.
研究者
研究点 (10)
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