NCT00358930已完成2 期
A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年7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
- 60
- 试验地点
- 18
- 主要终点
- Assess the overall response rate (ORR) of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with ARQ 501.
研究概览
简要总结
This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).
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
- •Able to provide signed and dated informed consent document prior to study-specific screening procedures.
- •Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
- •Measurable disease per RECIST.
- •≥ 18 years old.
- •Karnofsky performance status (KPS) ≥ 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 or less than or equal to 5.0 x ULN with metastatic liver disease.
- •Creatinine less than or equal to 1.5 x ULN.
排除标准
- •Primary tumor of nasopharyngeal origin.
- •Eligible for curative surgery or radiotherapy.
- •Received three or more systemic anticancer regimens.
- •Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- •Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
- •Surgery within two weeks of first infusion.
- •Have symptomatic or untreated central nervous system (CNS) involvement.
- •Are pregnant or lactating.
- •Previous exposure to ARQ 501.
结局指标
主要结局
Assess the overall response rate (ORR) of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with ARQ 501.
次要结局
- Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
研究者
研究点 (18)
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