NCT00277316终止2 期
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 18
- 主要终点
- Response rate
研究概览
简要总结
This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell carcinoma (RCC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.
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
- •Males and females with histologically confirmed metastatic clear cell RCC
- •Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- •No prior systemic cytotoxic chemotherapy
- •Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
- •ECOG performance status of 0 or 1
- •Life expectancy ≥3 months
- •Adequate organ and marrow function
- •No other malignancies within 5 years
- •Signed informed consent
排除标准
- •Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- •Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
- •Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered >30 days prior to study enrollment
- •History of or known brain metastases, current spinal cord compression or carcinomatous meningitis
- •Uncontrolled and/or intercurrent illness
- •Pregnant or breastfeeding females
- •Known HIV
结局指标
主要结局
Response rate
时间窗: Inclusion until disease progression
Safety and tolerability
时间窗: Inclusion until 30 days post last treatment
次要结局
- Progression-free survival(Inclusion until disease progression)
- Duration of response(Inclusion until disease progression)
- Overall survival(Inclusion until 180-day Follow-up post last treatment or death)
- Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters(Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.)
研究者
研究点 (18)
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