Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
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
- •RCC with metastases and nephrectomy
- •failure of prior sorafenib-based therapy
- •at least 1 target lesion that has not been irradiated
- •adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.
排除标准
- •Gastrointestinal abnormalities
- •current use or inability to avoid chronic antacid therapy
- •current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
- •active seizure disorder or evidence of brain metastases.
研究组 & 干预措施
AG-013736 (axitinib)
AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
干预措施: AG-013736 (axitinib) (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
次要结局
- Progression-free Survival (PFS)(Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks)
- Duration of Response (DR)(Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks)
- Overall Survival (OS)(Baseline to death due to any cause or at least 1 year after the first dose for the last participant)
- Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score(Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose))
- Population Pharmacokinetics of Axitinib (AG-013736)(Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks)