Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131 I Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.
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
- •Histologically documented thyroid cancer with metastases.
- •Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)
排除标准
- •Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
- •Patients with a history of hemoptysis
研究组 & 干预措施
Axitinib [AG-013736]
干预措施: AG013736 (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. 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 longest dimensions.
次要结局
- Progression-Free Survival (PFS)(Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks)
- Duration of Response (DR)(Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks)
- Overall Survival (OS)(Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant)