NCT00116389终止2 期
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Point Therapeutics55 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年6月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 55
- 主要终点
- 6 month survival
研究概览
简要总结
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.
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
- •Men or women age ≥18 years
- •Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
- •Measurable disease defined per RECIST
- •Karnofsky Performance Status ≥50
- •Expected survival ≥12 weeks
- •Provide written informed consent
排除标准
- •CNS metastases
- •Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
- •Radiation therapy to >25% of the bone marrow
- •Clinically significant laboratory abnormalities
- •Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- •The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
- •Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- •Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
- •Pregnancy or lactation
结局指标
主要结局
6 month survival
次要结局
- overall survival
- progression-free survival (PFS)
- quality of life
- pain
- performance status
研究者
研究点 (55)
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