A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine
详细描述
Additional study details: assess safety and efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
- •At least 1 measurable target lesion, as defined by RECIST
排除标准
- •Thyroid lymphoma
- •Previous treatment with anti-angiogenesis agents
- •No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.
研究组 & 干预措施
A
干预措施: AG-013736 (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (\>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study \>=4 weeks after initial documentation of response.
次要结局
- Progression Free Survival (PFS)(Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up))
- Duration of Response (DR)(Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up))
- Overall Survival (OS)(Baseline to death due to any cause or at least 2 year after the first dose for the last participant)
- Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score(Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up))
- Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score(Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up))