NCT00277290终止2 期
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 17
- 主要终点
- Response rate
研究概览
简要总结
This clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of XL999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with a histologically confirmed diagnosis of metastatic ovarian cancer
- •Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- •Prior treatment with platinum-based therapy
- •Platinum-sensitive or platinum-resistant disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of ≥3 months
- •Adequate organ and marrow function
- •Signed informed consent
- •No other malignancies within 5 years
排除标准
- •Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- •Use of an investigational drug or cytotoxic chemotherapy within 30 days of XL999 treatment
- •Prior anticancer therapy targeting VEGF (eg, bevacizumab, sorafenib, or sunitinib)
- •More than two prior systemic non-platinum cytotoxic chemotherapy regimens
- •Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to other 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
- •Patients who are pregnant or breastfeeding
- •Known human immunodeficiency virus (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
- Overall survival(inclusion until 180-Day Follow-up after last treatment or death)
- Progression-free survival(Inclusion until disease progression)
- Duration of response(Inclusion until disease progression)
- Pharmacokinetic (PK) and pharmacodynamics (PD) parameters(Samples will be collected pre-dose and immediatelyat the end of infusion for the 8-week Study Treatment Period for subjects in the second stage of the study)
研究者
研究点 (17)
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