NCT00556023已完成1 期
A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities: assessed through adverse event data collected weekly
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.
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
- 否
入选标准
- •Patients with metastatic pancreatic cancer
- •Patient must have adequate bone marrow, liver and kidney function
- •Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- •Chemotherapy naive
- •Inoperable pancreatic cancer
排除标准
- •Patient must not have received prior systemic therapy for pancreatic cancer
- •Patient must not have previously received anti-CTLA4 therapy
- •History of chronic inflammatory or autoimmune disease
研究组 & 干预措施
CP-675,206 and gemcitabine
Experimental
干预措施: CP-675,206 and gemcitabine (Drug)
结局指标
主要结局
Dose Limiting Toxicities: assessed through adverse event data collected weekly
时间窗: 8 week intervals
次要结局
- Pharmacogenomic Analysis:(1 month)
- Overall Survival:(12 months)
- Cytokine Analysis:(12 months)
- HAHA Response to CP-675,206:(12 months)
- Lymphocyte Subset Analysis:(12 months)
- Pharmacokinetics of CP-675,206 and Gemcitabine:(2 months)
- Best Overall Response:(3 months)
- Duration of Tumor Response:(3 months)
- Progression-Free Survival:(5 months)
研究者
研究点 (1)
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