EUCTR2012-000473-23-IT进行中（未招募）1 期
PHASE II STUDY OF SUNITINIB AS RECHALLENGE THIRD-LINE THERAPY IN METASTATIC RENAL CANCER
GIOM - Gruppo Italiano Oncologia Nefrologica0 个研究点开始时间: 2012年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically proven diagnosis of Renal Cell Carcinoma with predominant clear cell component. 2. First-line treatment with Sunitinib. 3. Patients with a Disease Control Rate (Complete Response + Partial Response + Stable Disease) lasting at least 10 months from first-line Sunitinib treatment. 4. Second-line treatment with Everolimus. 5. Age higher than 18. 6. ECOG Performance Status 0-2. 7. Life expectancy of at least 8 weeks. 8. Measurable lesions according to RECIST criteria. 9. Adequate cardiac, hepatic, renal, and bone marrow function. 10. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. First-line treatment with other compounds (excluding Sunitinib). 2. Symptomatic and/or unstable and/or not previously treated pre-existing brain metastases. 3. Uncontrolled hypertension. 4. Severe or uncontrolled cardiovascular diseases within 6 months of study. 5. Active uncontrolled infections. 6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
研究者
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