NCT00550004终止2 期
Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
SciClone Pharmaceuticals55 个研究点 分布在 12 个国家目标入组 153 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 153
- 试验地点
- 55
- 主要终点
- Overall Survival
研究概览
简要总结
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects must be 18 years of age or older
- •Not previously treated with chemotherapy for Pancreatic Cancer
- •ECOG performance status of 0 or 1
- •Life expectancy > 3 months
- •Documentation of all sites of pancreatic disease within 28 days prior to randomization
- •Adequate hematological, renal, and hepatic function
- •Not pregnant or nursing
- •Fertile subjects must practice a medically approved method of contraception
排除标准
- •Prior history of other malignant tumors
- •Participation in another investigational study within 4 weeks prior to treatment start
- •Major surgery within 14 days prior to treatment start
- •Radiation treatment within 28 days prior to treatment start
- •Uncontrolled cardiac atrial or ventricular arrhythmias
- •Gastrointestinal tract disease such resulting in an inability to take oral medication
- •Known to be seropositive for HIV, HBV, or HCV
- •Uncontrolled cancer pain
研究组 & 干预措施
Arm 1
Active Comparator
RP101 and Gemcitabine
干预措施: RP101 (Drug)
Arm 1
Active Comparator
RP101 and Gemcitabine
干预措施: Gemcitabine (1000 mg/m2) (Drug)
Arm 2
Placebo Comparator
Placebo and Gemcitabine
干预措施: Gemcitabine (1000 mg/m2) (Drug)
结局指标
主要结局
Overall Survival
时间窗: 18 months
次要结局
- Progression Free Survival(14 months)
- Evaluate the CA 19-9 levels(12 months)
- Compare changes in ECOG(12 months)
- Evaluate Safety of RP101(18 months)
研究者
研究点 (55)
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