A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Safety profile, including incidence and severity of adverse events
研究概览
简要总结
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).
详细描述
This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.
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
- •Diagnosis of RCC of predominantly clear cell histology
- •Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
- •At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
- •Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)
排除标准
- •Presence of acute infection or other significant systemic illness
- •Central nervous system involvement by malignancy
- •History of other cancer within 5 years
- •Previously received rIL-21 or sorafenib
结局指标
主要结局
Safety profile, including incidence and severity of adverse events
时间窗: During treatment and 28 days after last dose of rIL-21
次要结局
- Objective response rate at recommended dose of rIL-21(Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached)
- Progression-free survival at recommended dose of rIL-21(Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached)
- Pharmacokinetic profiles of rIL-21 and sorafenib(rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing)