NCT00810394已完成2 期
Single Agent Sorafenib in Advanced Solid Tumors: Phase II Evaluation of Dose Re-Escalation Following a Dose Reduction (IST000375)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.
详细描述
OBJECTIVES:
Primary
- To evaluate the feasibility of re-escalating the dose of sorafenib tosylate in patients with advanced malignant solid tumors who initially required a dose reduction for toxicity, and dose escalation in those patients who are able to tolerate the initial dose.
Secondary
- To evaluate the efficacy of this drug in these patients who are able to tolerate a dose escalation initially or after a dose reduction compared to those who are unable to tolerate a dose escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib
Experimental
Dose Re-Escalation Following a Dose Reduction
干预措施: Sorafenib (Drug)
结局指标
主要结局
Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity
时间窗: At least 3 months
Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.
次要结局
- Time to Disease Progression(Up to 2 years)
- Overall Response Rate(At least 3 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00754923Ohio State University Comprehensive Cancer Center11
已完成
2 期
Sorafenib. ICORG 06-41, V4Esophageal CancerGastric CancerNCT01158287Cancer Trials Ireland54
Unknown
1 期
Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV MelanomaMelanoma (Skin)NCT00811759Gustave Roussy, Cancer Campus, Grand Paris58
已完成
2 期
Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone TherapyProstate CancerNCT00589420Abramson Cancer Center at Penn Medicine18
已完成
2 期
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by SurgerySarcomaNCT00874874Centre Oscar Lambret88