NCT00617253已完成2 期
An Open Label, Dose Escalation Safety and Tolerability Trial of the Combination of s.c. Recombinant Human IL-21 (rIL-21) and Sunitinib (Phase 1) Followed by an Open Label Stratified Randomized 2-arm Trial of rIL-21 Plus Sunitinib Versus Sunitinib Alone (Phase 2a) in Subjects With Stage IV Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Toxicity according to CTCAE version 3.0
研究概览
简要总结
This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.
The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.
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 verified and surgically incurable stage IV Renal Cell Carcinoma
- •ECOG performance status of 0 or 1 (i.e. good performance status)
- •Life expectancy of at least 3 months
排除标准
- •Prior systemic therapy for metastatic disease
- •Radiotherapy within the last 4 weeks prior to start of treatment
- •Receipt of any investigational drug within 3 months of starting treatment
- •History of any other active malignancy within five years prior to enrolment
研究组 & 干预措施
B
Experimental
干预措施: sunitinib (Drug)
B
Experimental
干预措施: recombinant interleukin-21 (Drug)
C
Experimental
干预措施: sunitinib (Drug)
A
Experimental
干预措施: recombinant interleukin-21 (Drug)
A
Experimental
干预措施: sunitinib (Drug)
C
Experimental
干预措施: recombinant interleukin-21 (Drug)
D
Experimental
干预措施: sunitinib (Drug)
D
Experimental
干预措施: recombinant interleukin-21 (Drug)
结局指标
主要结局
Toxicity according to CTCAE version 3.0
时间窗: For the duration of the trial
次要结局
- Pharmacokinetics(For the duration of the trial)
- rIL-21 antibodies(For the duration of the trial)
研究者
研究点 (1)
Loading locations...
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