EUCTR2006-001942-15-DE进行中（未招募）不适用
A Phase 2 Study of ARQ 501 in Patients with Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ARQule Inc.
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to provide signed and dated informed consent document prior to study-specific screening procedures
- •2. Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN
- •3. Measurable disease as defined by RECIST (see section 9.0)
- •4. Age greater or equal 18years
- •5. Karnofsky performance status greater or equal 70 % (see Appendix B)
- •6. 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 ARQ501.
- •7. Hemoglobin (Hgb) greater or equal 10 g/dl
- •8. Absolute neutrophil count (ANC) greater or equal 1500/mm³
- •9. Platelet count greater or equal 100.000/mm³
- •10. Total bilirubin lower or equal 1.5 * upper limit of normal (ULN) or lower or equal 3.0 * ULN with metastatic liver disease
- •11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) lower or equal 2.5 * ULN or lower or equal 5.0 ULN with metastatic liver disease
- •12. Creatinine lower or equal 1.5 ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary tumor of nasopharyngeal origin
- •2. Eligible for curative surgery or radiotherapy
- •3. Received three or more anticancer regimens
- •4. Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment
- •5. Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion
- •6. Surgery within two weeks of first infusion
- •7. Have symptomatic or untreated central nervous system (CNS) involvement
- •8. Are pregnant or lactating
- •9. Previous exposure to ARQ501
研究者
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