AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 492
- 试验地点
- 96
- 主要终点
- Progression Free Survival (PFS): First-Line Participants
研究概览
简要总结
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Histologically documented metastatic renal cell cancer with a component of clear cell histology.
- •Evidence of measurable disease.
- •Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
排除标准
- •Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
- •Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
研究组 & 干预措施
A
干预措施: Axitinib (AG-013736) (Drug)
B
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival (PFS): First-Line Participants
时间窗: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Progression Free Survival (PFS): Second-Line Participants
时间窗: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
次要结局
- Percentage of Participants With Objective Response (OR): First-Line Participants(Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107))
- Percentage of Participants With Objective Response (OR): Second-Line Participants(Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))
- Duration of Response (DR): First-Line Participants(Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107))
- Duration of Response (DR): Second-Line Participants(Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))
- Overall Survival (OS): First-Line Participants(Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107))
- Overall Survival (OS): Second-Line Participants(Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))