NCT00313794已完成2 期
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
研究概览
简要总结
This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.
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
- •Radiographic evidence of metastatic, progressive disease following standard therapies.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
排除标准
- •Known brain metastases or uncontrolled pleural effusions.
- •History of chronic inflammatory or autoimmune disease.
研究组 & 干预措施
1
Experimental
single arm
干预措施: CP-675,206 (Drug)
结局指标
主要结局
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
时间窗: 18 months
次要结局
- To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206.(3 yrs)
- To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.(3 yrs)
- To evaluate the safety and tolerability of CP-675,206 in this population.(18 mos)
- To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.(2 yrs)
- To identify any human anti human antibody (HAHA) response to CP-675,206 .(3 yrs)
研究者
研究点 (1)
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