NCT00406601已完成2 期
Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Progression free survival rate
研究概览
简要总结
The aim of this study (*) is to evaluate the progression free survival rate at 6 months, response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue sarcoma patients.
(*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007
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
- •Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line anthracycline-based regimen; age >=18 yrs; ECOG PS =2; at least 1 measurable target lesion; life expectancy >=12 wks; adequate medullary liver and renal function; written informed consent.
排除标准
- •metastatic brain disease; pregnant or breast-feeding patients; serious infections.
结局指标
主要结局
Progression free survival rate
时间窗: at 6 months after enrollment
次要结局
- Overall response rate, overall disease control rate, overall survival(Tumor assessment, follow-up)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell CarcinomaCarcinoma, Renal CellNCT00117637Bayer189
已完成
2 期
A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung CancerNon Small Cell Lung CancerNCT00735696Eli Lilly and Company41
Unknown
2 期
Study of AR-67 in Adult Patients With Recurrence of Glioblastoma Multiforme (GBM) or GliosarcomaGliosarcomaGBMGlioblastoma MultiformeNCT01124539Arno Therapeutics58
已完成
2 期
A Study of MEDI-575 in Subjects With Recurrent Glioblastoma MultiformeGlioblastoma MultiformeNCT01268566MedImmune LLC62
已完成
2 期
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)Carcinoma, Non-Small Cell LungCancerNCT00101413Bayer52