An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced and/or Recurrent Endometrial Cancers With Specific FGFR2 Mutations
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Response rate
研究概览
简要总结
An open-label, non-randomized, single arm study to assess the safety, tolerability, and pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly starting at a dose of up to 16 mg/kg.
详细描述
FP-1039 will be administered intravenously over 30 minutes once a week. All enrolled subjects will be monitored for the occurrence of unacceptable toxicity. Subjects with no evidence of disease progression or unacceptable toxicity after 4 doses of FP-1039 may continue to receive weekly treatment provided there continues to be no evidence of disease progression or unacceptable toxicity. Dosing will be discontinued if a subject has evidence of disease progression. Disease will be assessed approximately every 2 months.
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
- Female
- 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
FP-1039
FP-1039
干预措施: FP-1039 (Drug)
结局指标
主要结局
Response rate
时间窗: up to 1 year
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Progression-free survival
时间窗: 6 months
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
次要结局
- Safety and tolerability(up to 1 year)
- Pharmacokinetics of Plasma(up to 1 year)