Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
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
- 2 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
- •Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"
排除标准
- •Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
- •Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
- •Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- •Patients with active bleeding
- •Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
- •Pregnant or nursing women
- •Patients who can not swallow the pill
研究组 & 干预措施
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
干预措施: Pazopanib (Drug)
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
干预措施: Ifosfamide (Drug)
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
干预措施: Carboplatin (Drug)
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
干预措施: Etoposide (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
时间窗: 42 days
Definition of dose-limiting toxicity (DLT) * Hematologic DLT: delayed recovery of ANC/platelets \> 42 days * Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding * Grade 2 arterial thrombosis * Any grade 4 toxicities except hematologic toxicities
次要结局
- Rate of tumor response (brain tumor)(4 weeks)
- Rate of tumor response (other solid tumors)(4 weeks)
- Rate of tumor response (neuroblastoma)(4 weeks)