A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer
详细描述
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age ≥18 years and ≤70 years, signed informed consent.
- •Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
- •Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
- •At least treated with one line of platinum-based chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125
- •Patients must have a life expectancy of at least 3 months.
- •Patients must have adequate organ function.
排除标准
- •Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension
- •History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day
- •History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
- •Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1
- •Symptomatic central nervous system (CNS) metastasis
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to three years
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
次要结局
- Progression-free survival (PFS)(Up to three years)
- Duration of Response(Up to three years)
- Frequency and severity of adverse effects as defined by CTCAE version 4.03(30 days after last dose)