Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender.
- •Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
- •Unequivocal progression of measurable disease.
- •A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
- •First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
- •Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.
排除标准
- •Failure to meet any of the above inclusion criteria.
- •Concurrent treatment with other cytotoxic drugs or targeted therapies.
- •Prior radiation therapy within 14 days of trial start.
研究组 & 干预措施
Pazopanib
Patients will receive pazopanib at the dose of 800 mg/day orally until disease progression or evidence of unacceptable toxicity/side effects. The study will be performed according to Simon's two-stage optimal design.
干预措施: Pazopanib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 3-months
To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
次要结局
- Response Rate(3 months)
- Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03(3 months)
- Overall survival (OS)(6 months)
研究者
Andrea Necchi
Faculty, Department of Medical Oncology
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano