A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Alveolar soft part sarcoma (ASPS), a rare subset of STS (<1%) harbors t(X;17)(p11;q25) translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high expression of angiogenic factors, sunitinib and cediranib produced overall response rates of 55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.
详细描述
Pazopanib, a multi-targeted anti-angiogenesis inhibitor significantly prolonged progression-free survival (PFS) in patients with metastatic soft-tissue sarcoma (STS) after failure to anthracycline-based regimen (pazopanib vs placebo, 4.6 vs 1.6 months, HR=0.31, 95% CI 0.24-0.40; P < .0001). Regarding sunitinib (continuous daily dose of 37.5mg), after a median duration of 10 months, median OS and PFS were 19 months and 17 months, respectively in a small retrospective study (ASPS, N=9). With regard to cediranib, 6-month PFS was over 60%. In addition, randomized phase II trial of sunitinib vs cediranib with cross-over at disease progression was recently initiated (NCT01391962). However, the efficacy of pazopanib is unknown in metastatic ASPS.
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
- •Histologically confirmed diagnosis of alveolar soft part sarcoma harboring TFE3 fusion at stage IV or at relapse
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Measurable lesion defined by RECIST v1.1
- •Chemo-naïve or prior chemotherapies
- •Adequate organ function
排除标准
- •Prior malignancies
- •Active CNS disease
- •High-risk for gastrointestinal bleeding
- •Significant cardiovascular disease
- •Uncontrolled hypertension
- •Bleeding diathesis
研究组 & 干预措施
Pazopanib
Pazopanib 800mg po qd until disease progression
干预措施: Pazopanib (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: One year
ORR based on RECIST v1.1
次要结局
- Progression-free survival(6 month)
- Overall survival(Two years)
- Number of Participants with Adverse Events(One year)
研究者
Tae Min Kim
MD, PhD
Seoul National University Hospital