A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
详细描述
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Locally advanced or metastatic NSCLC
- •Measurable disease
- •ECOG PS 0 or 1
排除标准
- •Known CNS metastasis
- •Pre-existing autoimmune or antibody mediated disease
研究组 & 干预措施
B
Standard of care chemotherapy
干预措施: pemetrexed (Drug)
A
Standard of care chemotherapy plus experimental intervention (PF-3512676)
干预措施: pemetrexed + PF-3512676 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 110 Events
次要结局
- Overall Survival(Time of death)
- Duration of Response(Time of disease progression)
- Overall Safety Profile(28 days post treatment)
- Patient Reported Outcome(End of Treatment)
- Time to Tumor Progression(End of treatment)
- Overall Objective Response Rate(Time of disease progressive disease)