ACTRN12609000002280进行中（未招募）2 期
Phase II, Multicenter, Open-Label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Eisai Inc
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Patients must have histologically or cytologically confirmed diagnosis of Medullary Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC).
- •2.Measurable disease meeting the following criteria:
- •-- Radiographically measurable disease defined as at least one lesion that can be accurately measured in 1 dimension as at least 20 mm by conventional Computed tomography (CT) or magnetic resonance imaging (MRI) techniques or as at least 10 mm by spiral CT scan.
- •3.Patients must show evidence of disease progression by RECIST using site assessment of CT/MRI scans within 6 months (+ 1 month to allow for variances in patients scanning intervals) prior to study entry.
- •4.Patients with DTC must be 131-I refractory/resistant disease: never demonstrated 131-I uptake or progression despite 131-I uptake, or cumulative dose of 131-I of > 600 mCi (last dose given at least 6 months prior to study entry).
- •5.Well controlled blood pressure prior to study entry.
- •6.Signed informed consent.
排除标准
- •1.Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid
- •2.Brain or leptomeningeal metastases
- •3.Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia)
- •4.Marked baseline prolongation of QT/QTc interval
- •5.Proteinuria > 1+ or > 30 mg in dipstick testing
- •6.Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry
研究者
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