NCT00372853已完成1 期
A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
研究概览
简要总结
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 proven renal cell carcinoma with metastases
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
排除标准
- •Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
- •History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
研究组 & 干预措施
Arm A
Experimental
干预措施: CP-675,206 (Drug)
Arm A
Experimental
干预措施: SU011248 (Drug)
Arm B
Experimental
干预措施: CP-675,206 (Drug)
Arm B
Experimental
干预措施: SU011248 (Drug)
结局指标
主要结局
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
时间窗: 6 weeks after first dose
次要结局
- To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported(18 months)
- To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination(up to 18 months)
- To monitor for an antibody response to CP-675,206(up to 18 months)
- To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled(6-18 months after last subject enrolled)
研究者
研究点 (1)
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