EUCTR2012-004910-33-IT进行中（未招募）1 期
Phase II study of single-agent Pazopanib (Votrient) for patients with relapsed or refractory germ-cell tumors (GCT). - PAZOTEST-01
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点目标入组 43 人开始时间: 2012年12月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Age > 18 years.
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
- •- A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease (enrollment will take place either as 3rd or 4th line of treatment), EXCEPT FOR primary mediastinal nonseminomas, to which the 2nd line setting will apply.
- •- 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.
- •- Adequate hematopoietic and organ function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Significant comorbidities that preclude the administration of Pazopanib.
- •2.Severe ongoing infections, grade > 2 of the CTCAE v.4.03..
- •4. Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are ineligible. In general, these patients are recommended for initial surgical extirpation rather than chemotherapy or other drugs. Patients with late relapse who have either unresectable disease or highly elevated markers will be eligible.
- •5. More than 3 prior chemotherapy regimens.
- •6. Prior cancer except for basal cell carcinoma and any other cancer that has been cured since 5 years before.
- •7. Any medical and psychiatric conditions that could jeopardize the observation of protocol procedures.
研究者
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