NCT01688999已完成2 期
A Phase II Study of Cabozantinib (XL184) in Patients With Advanced/Metastatic Urothelial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Response
研究概览
简要总结
Background:
- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urothelial cancer.
Objectives:
- To test the safety and effectiveness of cabozantinib for advanced urothelial cancer.
Eligibility:
- Individuals at least 18 years of age who have advanced urothelial cancer that has not responded to standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples will also be collected. Imaging studies will also be performed.
- Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle.
- Treatment will be monitored with frequent blood tests and imaging studies.
- Participants will continue to take the study drug for as long as their cancer does not worsen and side effects are not too severe.
详细描述
Background:
- In the United States, urothelial carcinoma (UC) of the bladder is the fourth most common malignancy in men and the ninth most common in women with an estimated 69,250 new cases and 14,990 deaths in the year 2011
- There is no Food and Drug Administration (FDA)-approved second line drug for patients with metastatic Urothelial Cancer (UC)
- Multiple lines of evidence support targeting angiogenesis in UC
- In human bladder cancer, overexpression of tyrosine-protein kinase (c-Met)/Axl/platelet derived growth factor receptor- (PDGFR)-alpha or c-Met alone showed significant correlation with poor survival
- Cabozantinib is a new chemical entity that inhibits multiple receptor tyrosine kinases with growth-promoting and angiogenic properties.
- The primary targets of cabozantinib are mesenchymal epithelial transition factor (MET), vascular endothelial factor receptor 2 (VEGFR2), and rearranged during transfection (RET)
Objectives:
- To determine the response rate of cabozantinib in patients with progressive urothelial cancer who have received prior cytotoxic chemotherapy
Eligibility:
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 99 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
Experimental
Administered orally at a dose of 60 mg once daily on each day of a 28-day cycle.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Percentage of Participants With Overall Response
时间窗: Median follow-up was 61.2 months
Complete Response (CR) or Partial Response (PR) to Cabozantinib (XL184) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. 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.
次要结局
- Overall Survival(Median follow-up was 61.2 months)
- Number of Participants With Grade 4 Toxicity Hypomagnesium Related to Cabozantinib(Median follow-up was 61.2 months)
- Progression Free Survival(Median follow-up was 61.2 months)
- Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution(Median follow-up was 61.2 months)
研究者
Andrea Apolo, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Cabozantinib for Adults With Advanced Soft Tissue SarcomaRefractory Soft Tissue SarcomasNCT01755195National Cancer Institute (NCI)55
已完成
1 期
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate CancerProstatic NeoplasmsNCT01683994National Cancer Institute (NCI)49
已完成
2 期
Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid TumorsCarcinoid TumorPancreatic Neuroendocrine TumorNCT01466036Dana-Farber Cancer Institute61
招募中
2 期
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL ActivityNon-Small Cell Lung CancerNCT01639508Memorial Sloan Kettering Cancer Center86
已完成
2 期
A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral MetastasesProstate CancerNCT01834651Edwin Posadas, MD17