An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 7
- 主要终点
- Length of Exposure to NKTR-102
研究概览
简要总结
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NKTR-102
干预措施: NKTR-102 145 mg/m2 (Drug)
NKTR-102
干预措施: NKTR-102 120 mg/m2 (Drug)
NKTR-102
干预措施: NKTR-102 95 mg/m2 (Drug)
NKTR-102
干预措施: NKTR-102 50 mg/m2 (Drug)
结局指标
主要结局
Length of Exposure to NKTR-102
时间窗: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
次要结局
- Adverse Events(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)
- Efficacy of NKTR-102(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)
- Disease Status(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)