Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations Independent of HER2 Expression With Progression After Previous Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Antitumor effect of axitinib (INLYTA) among patients with solid tumors with BRCA 1/2 mutations independent of HER2 expression, with progression after previous treatment, including radiotherapy
研究概览
简要总结
This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.
The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.
详细描述
This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.
The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.
The addition of Axitinib to existing treatment protocols and to fractionated irradiation without functional normalization of the tumor vasculature can significantly improve response to therapy, contributing to the breakdown of the metabolic symbiosis of adaptive drug resistance.
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 and immunohistochemically confirmed status of the tumor process
- •мale or female, age ≥ 18 years
- •Karnofsky performance status ≥ 60
- •signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
排除标准
- •Grade 3 bleeding NCI CTCAE prior to study enrollment
- •cardiac arrhythmias ≥2 according to NCI CTCAE with a corrected QT interval (QTcF) on the screening ECG >480 ms.
- •pregnancy or breastfeeding. All female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must consent to the use of effective contraception during therapy.
- •severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study
- •congestive heart failure (CHF) class III or higher according to the New York Heart Association (NYHA)
- •subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)
研究组 & 干预措施
Axitinib is 5 mg BID administered orally
The starting dose of Axitinib 5 mg BID administered orally with food.
干预措施: Axitinib (Drug)
结局指标
主要结局
Antitumor effect of axitinib (INLYTA) among patients with solid tumors with BRCA 1/2 mutations independent of HER2 expression, with progression after previous treatment, including radiotherapy
时间窗: up to 90 days
Percent reduction of longest diameter of tumor and (or) metastases in millimeters
次要结局
未报告次要终点