NCT00560560已完成2 期
A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Estimate of the 6 Month Survival Probability
研究概览
简要总结
This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.
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
- •Patients who have stage IV colorectal cancer
- •Patients whose disease has worsened despite prior anti-cancer therapy
- •Patients who have satisfactory bonemarrow, kidney and liver function
排除标准
- •Patients who are being simultaneously treated with another anti-cancer therapy.
- •Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
- •Patients that are pregnant or breast-feeding
结局指标
主要结局
Estimate of the 6 Month Survival Probability
时间窗: Baseline up to Month 6
The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
次要结局
- Overall Survival(From date of enrollment until death or censorship, up to 33 months)
- Progression-Free Survival (PFS)(Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.)
- Percentage of Participants With Objective Response(Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months)
- Descriptive Summary of Figitumumab Concentration Versus Time(Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5)
- Participants Reporting Positive for Total Anti-drug Antibodies (ADA)(Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion))
- Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)(Cycle 1 pre-dosing and Cycle 4 pre-dosing)
- Counts of Circulating Tumor Cells (CTCs)(Cycle 1 pre-dosing and Cycle 4 pre-dosing)
研究者
研究点 (12)
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