NCT00322517已完成2 期
A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
研究概览
简要总结
To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer
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
- •Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
- •Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.
排除标准
- •Prior treatment with >/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes
- •Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic
研究组 & 干预措施
SU014813
Experimental
干预措施: SU014813 (Drug)
结局指标
主要结局
To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
时间窗: June 2008
次要结局
- To assess onset and duration of tumor control and 1-year survival rate(AUG 2008)
- To evaluate the safety of SU-014813To assess patient reported outcomes(AUG 2008)
- To determine SU-014813 plasma trough concentration (Ctrough)(AUG 2008)
- To explore the relationship between Ctrough and efficacy, safety, and biomarkers(AUG 2008)
- To explore the correlations of cancer biomarkers with treatment-related outcomes(AUG 2008)
研究者
研究点 (1)
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