NCT00056693已完成2 期
A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Radiographic objective disease response
研究概览
简要总结
To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.
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 or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
- •Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
- •ECOG performance status 0 or 1
排除标准
- •Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
- •Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.
研究组 & 干预措施
A
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Radiographic objective disease response
时间窗: From screening until disease progression or discontinuation of study
次要结局
- To assess safety (adverse events and lab abnormalities)(From screening until patient death or discontinuation of study)
- To assess patient-reported outcomes and treatment-related symptoms(From screening until patient death or discontinuation of study)
- To assess pharmacokinetics and biomarkers(From screening until patient death or discontinuation of study)
- To assess overall survival at 1 year(From screening until patient death or discontinuation of study)
- To assess other measures of antitumor efficacy including TTP and survival(From screening until patient death or discontinuation of study)
研究者
研究点 (1)
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