A Phase 2 Study of Cabozantinib (XL184), a Dual Inhibitor of MET and VEGFR, in Patients With Metastatic Refractory Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective Response (Complete Response (CR)+Partial Response (PR) of Cabozantinib in Patients With Soft Tissue Sarcomas
研究概览
简要总结
Background:
- Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not responded to earlier treatments.
Objectives:
- To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have soft tissue sarcomas that have not responded to standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment.
- Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The tablets should be taken whole on an empty stomach.
- Treatment will be monitored with frequent blood tests and imaging studies.
- Participants will continue to take cabozantinib for as long as the tumor does not become worse and the side effects are not too severe.
详细描述
Background:
- Soft tissue sarcomas (STS) are a relatively rare heterogeneous group of tumors that constitute about 1% of adult cancers.
- The mainstay of treatment for advanced disease has been palliative chemotherapy with a median overall survival of approximately 12 months. This has not changed considerably in the past years and there is an unmet need for newer targeted therapies.
- Vascular endothelial growth factor (VEGF) levels are elevated in patients with STS and various sarcoma cell lines express high levels of activated c-Met receptor.
- We hypothesize that dual targeting of the VEGF and mesenchymal-epithelial transition factor (c-MET) pathways with cabozantinib would result in clinical benefit in patients with soft tissue sarcoma.
Objectives:
Primary:
- Assess the response rate (Complete Response (CR)+Partial Response (PR) of cabozantinib in patients with soft tissue sarcomas.
- Assess the 6 month progression free survival (PFS) of cabozantinib in soft tissue sarcomas.
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 120 Years（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
Cabozantinib
60 mg tablets orally once a day in a 28-day cycle.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Objective Response (Complete Response (CR)+Partial Response (PR) of Cabozantinib in Patients With Soft Tissue Sarcomas
时间窗: Date treatment consent signed to date off study, approximately 86 months and 3 days.
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Percentage of Participants With 6 Month Progression Free Survival (PFS)
时间窗: 6 months
Progression in participants with soft tissue sarcomas treated with cabozantinib was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
次要结局
- Mean Change From Baseline in Levels of Circulating Hepatocyte Growth Factor (HGF)(Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1)
- Mean Change From Baseline in Levels of Circulating Soluble Mesenchymal Epithelial Transition Factor (sMET)(Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1)
- Mean Change From Baseline in Levels of Circulating Vascular Endothelial Growth Factor A (VEGF-A)(Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1)
- Mean Change From Baseline in Levels of Circulating Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR-2)(Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1)
研究者
Alice Chen, M.D.
Principal Investigator
National Cancer Institute (NCI)