NCT00121628已完成2 期
A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 184
- 主要终点
- Objective Response Rate (complete response and partial response) as defined by modified RECIST
研究概览
简要总结
The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.
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 confirmed locally advanced or metastatic thyroid cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - Evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - Evidence of disease progression within 6 months before starting study OR symptomatic disease (for medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age
排除标准
- •Undifferentiated/anaplastic thyroid cancer - Untreated or symptomatic brain metastases - Prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein thrombosis within 1 year before starting study
结局指标
主要结局
Objective Response Rate (complete response and partial response) as defined by modified RECIST
次要结局
- Progression Free Survival
- Tumour Related Symptoms (medullary thyroid cancer arm)
- Duration of response
- Changes in tumor markers
- time to response
- overall survival time
- AMG 706 pharmacokinetic profile
- patient reported outcome (EQ-5D)
- Safety Endpoint: Incidence of treatment-emergent adverse events (including all, serious, treatment-related, and each by maximum severity).
- Pharmacokinetic Enpoint: AMG 706 pharmacokinetic parameters (Cmax, t1/2, AUC0-24,C24)
研究者
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