NCT01219751Unknown2 期
Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma
详细描述
There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type.
This study is to evaluate efficacy and safety of sunitinib in this group of patients.
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 or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type
- •Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- •Measurable disease according to RECIST criteria
- •ECOG performance status 1 or better
- •Age 18 years or older
- •Adequate cardiac function
- •Adequate bone marrow, hepatic, and renal function
- •Life expectancy of ≥ 3 months
- •Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
排除标准
- •Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type
- •Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
- •Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
- •Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
- •Pregnancy or breast feeding.
- •Other severe acute or chronic medical or psychiatric condition
- •Prior treatment on sunitinib, sorafenib, or bevacizumab.
研究组 & 干预措施
Sunitinib
Experimental
Sunitinib 50 mg D1-D28 every 6 weeks
干预措施: Sunitinib (Drug)
结局指标
主要结局
Response rate
时间窗: up to 12 months
Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category.
次要结局
- Progression free survival(up to 24 months)
- overall survival(up to 36 months)
- Safety(up to 24 months)
研究者
研究点 (1)
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