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临床试验/NCT00245362
NCT00245362已完成2 期

A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Cell Genesys2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2002年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Safety

研究概览

简要总结

To evaluate the safety and effectiveness of CG8020 and CG2505.

详细描述

To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
  • Chemotherapy naïve or chemotherapy experienced pancreatic cancer

排除标准

  • Prior cancer vaccines or gene therapy
  • History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
  • History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

结局指标

主要结局

Safety

Efficacy measured by clinical benefit response

Progression-free survivial

Overall survival

次要结局

未报告次要终点

研究者

发起方
Cell Genesys
申办方类型
Industry

研究点 (2)

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