Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Clinical Benefit
研究概览
简要总结
This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used.
- •ECOG performance status of 0-
- •At least one measurable lesion per RECIST.
- •Age greater than or equal to 20 years.
- •Japanese, Chinese, or Korean ethnicity.
排除标准
- •CNS metastases at screening or history or CNS metastases.
- •Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC.
- •In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
研究组 & 干预措施
A.
干预措施: Temsirolimus (CCI-779) (Drug)
B.
干预措施: Temsirolimus (CCI-779) (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Benefit
时间窗: Baseline Up to 4 years
Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
次要结局
- Progression-free Survival (PFS)(Baseline Up to 4 years)
- Percentage of Participants With Objective Response(Baseline Up to 4 years)
- Duration of Response(Baseline Up to 4 years)
- Time to Treatment Failure (TTF)(Baseline Up to 4 years)
- Overall Survival (OS)(Baseline Until Death (Up to 4 years))