Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
研究概览
简要总结
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
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
- •Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
- •Patient with at least one measurable lesion.
- •Patient with ECOG performance status 0 or 1.
排除标准
- •Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
- •Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
- •Patient who has mAb therapy other than rituximab as prior line of therapy.
- •Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
- •Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
GP2013
干预措施: GP2013 (Drug)
结局指标
主要结局
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
时间窗: 12 weeks
Time to reach maximum concentration of GP2013
时间窗: 12 weeks
To evaluate safety of GP2013
时间窗: 12 weeks
Adverse events, laboratory abnormalities
Maximum observed concentration of GP2013
时间窗: 12 weeks
Minimum (trough) observed concentration during each dosing interval of GP2013
时间窗: 12 weeks
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
时间窗: 12 weeks
Elimination half-life associated with the terminal slope of GP2013
时间窗: 12 weeks
次要结局
- To evaluate efficacy of GP2013(12 weeks)
- To evaluate the incidence of immunogenicity (ADA formation) against GP2013(12 weeks)
- To evaluate peripheral CD19+ B-cell count(12 weeks)