NCT00319683终止1 期
A Phase 1/2 Study in Subjects With Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma, Evaluating the Safety, and Anti-Tumor Activity of ADH300004 (Eniluracil) With Escalating Doses of 5 Fluorouracil Administered Orally Once Weekly for 3 Weeks Out of Every 4 (Adherex Protocol Number AHX-03-103)
Adherex Technologies, Inc.10 个研究点 分布在 3 个国家开始时间: 2006年4月27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
- 试验地点
- 10
研究概览
简要总结
5-fluorouracil (5-FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will test the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.
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
- •In the Phase I portion, Asian subjects that are > or = to 18 years of age
- •In the Phase II portion, any subjects that are > or = to 18 years of age
- •Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein [AFP] > 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein [AFP] > 400 ng/mL, hepatitis B surface antigen negative)
- •Radiologically documented measurable disease
- •Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
- •Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study
排除标准
- •Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry
- •No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy)
- •Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
- •Ascites that is refractory to conservative management
- •Inability to take oral medication
- •Active peptic ulcer disease
- •Known hypersensitivity to 5-FU or ADH300004
- •History of primary brain tumors or brain metastases
- •Previous or concurrent malignancy at another site within the last 5 years
- •Stroke, major surgery, or other major tissue injury within 30 days before study entry
研究者
研究点 (10)
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