NCT00277329终止2 期
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 8
- 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 non-small cell lung cancer (NSCLC). 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 NSCLC
- •Prior treatment with a platinum- or taxane containing regimen
- •Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)
- •Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- •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
- •Use of any systemic anticancer therapy within 30 days of XL999 treatment
- •More than 2 prior systemic cytotoxic chemotherapy regimens
- •More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)
- •Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days before study enrollment
- •Uncontrolled and/or intercurrent illness
- •History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
- •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 dyas 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(Various time points during the 8-week Study Treatment Period in the second stage of the study)
研究者
研究点 (8)
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