NCT01118065Unknown2 期
A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
Secondary
- To determine maximum percentage of tumor reduction in these patients.
- To describe activity time to event endpoints.
- To assess toxicity.
- To determine evolution of serum thyroglobulin.
- To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
- To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
- •Progressive or recurrent disease
- •Metastatic disease
- •Unresectable disease
- •Meeting any of the following thyroid cancer subtypes:
- •Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
- •Undifferentiated thyroid cancer (i.e., anaplastic disease)
- •Medullary thyroid cancer
- •Must have received prior everolimus or other mTOR inhibitor therapy
- •Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance score 70-100%
- •ANC ≥ 1,500/mm^³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 5.6 mmol/L
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
- •Serum creatinine ≤ 2 times ULN
- •Negative pregnancy test
- •No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Efficacy
次要结局
- Maximum percentage of tumor reduction
- Activity time to event endpoints
- Toxicity
研究者
研究点 (2)
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