A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Clinical Benefit Response Rate (CBR)
研究概览
简要总结
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)
排除标准
- •Patients with poorly differentiated neuroendocrine cancer are not eligible
研究组 & 干预措施
Sunitinib arm
干预措施: Sunitinib (Drug)
结局指标
主要结局
Clinical Benefit Response Rate (CBR)
时间窗: Up to 799 days of treatment
CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.
次要结局
- Objective Response Rate (ORR)(Up to 799 days of treatment)
- Tumor Shrinkage(Up to 799 days of treatment)
- Progression-free Survival (PFS)(Up to 799 days of treatment)
- Overall Survival (OS)(Up to 3 years from the last subject registration to the study)
- Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).(Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1)