A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 23
- 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 paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
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/survival follow-up. Data collection was completed on 22 May 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
- •Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer
- •ECOG Performance Status 0-1
- •Measurable disease per RECIST criteria
排除标准
- •Squamous cell, small cell, or carcinoid lung cancer
- •CNS metastasis
- •Pre-existing autoimmune or antibody mediated disease
- •Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs
研究组 & 干预措施
B
Standard of care chemotherapy
干预措施: paclitaxel + carboplatin + bevacizumab (Drug)
A
Standard of care chemotherapy plus experimental intervention (PF-3512676)
干预措施: carboplatin + paclitaxel + bevacizumab + PF-3512676 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 110 Events
次要结局
- Overall safety profile(28 days post treatment)
- Time to Tumor Progression(End of treatment)
- Overall Objective Response Rate(Time of progressive disease)
- Duration of Response(Time of progression)
- Overall Survival(Time of death)