Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.
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 non squamous cell, lung cancer
- •No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment
排除标准
- •Prior therapy for advanced lung cancer
- •The need for blood-thinners
- •Coughing up blood
研究组 & 干预措施
B
Bevacizumab will be administered in combination with carboplatin and paclitaxel.
干预措施: Bevacizumab (Drug)
B
Bevacizumab will be administered in combination with carboplatin and paclitaxel.
干预措施: Carboplatin (Drug)
B
Bevacizumab will be administered in combination with carboplatin and paclitaxel.
干预措施: Paclitaxel (Drug)
A
AG-013736 will be administered in combination with carboplatin and paclitaxel.
干预措施: AG-013736 (axitinib) (Drug)
A
AG-013736 will be administered in combination with carboplatin and paclitaxel.
干预措施: Carboplatin (Drug)
A
AG-013736 will be administered in combination with carboplatin and paclitaxel.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years
Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
次要结局
- Overall Survival (OS)(Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years))
- Percentage of Participants With Objective Response (OR)(Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years)
- Duration of Response (DR)(Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years)
- Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)(Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1)
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score(Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years))
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score(Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years))
- Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood(Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1)
- Circulating Endothelial Cells (CEC) in Blood: Total CEC(Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1)
- Circulating Endothelial Cells (CEC) in Blood(Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1)
- Plasma Concentration of Soluble Proteins(Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1)